C6. HAZARDS ARISING FROM FUNCTIONAL FAILURE, MAINTENANCE AND AGEING
1. Inadequacy of performance characteristics for the intended use
ITEMS
HAZARDS/ TYPE OF
HARM/
P
ERROR
CONSEQUENCES
A
Air compression
Failure on compression
system:
too fast,
too slow,
not enough,
no compression
Overpressure,
Unable to complete
therapies, injury,
Barotrauma / Heat
X
X
Cylinder gas
storage HP
Lack of volume / size
Unable to complete
therapies if power cut
X
X
Cylinder gas
storage LP
Lack of volume / size
Unable to complete
therapies if power cut
X
X
Pipework for all
gases
Inadequate / size /
pressure rating / material
X
X
X
4
Reducers
Failure open / free-flow
Unable to carry on
treatment / injury
damage/ explosion
Damage to pressure
vessels / explosion /
rupture
X
X
X
4
DCI,
X
X
FO2 increase, Fire
danger, Hyperoxia,
Noise / unnecessary
ventilation / suction
injury / blockage
Inability to complete
treatments safely
X
X
X
X
Air decompression Failure on
decompression,
Too slow,
too fast,
no decompression
Air ventilation
Not adequate, failure,
Inadequate size / not
protected / not well placed
to avoid pocketing of 02
O
2, 3, 5
5
X
Heating /Cooling
Insufficient / poor
Humidification
Incorrect levels
Static/Sparks/ Fire
/Shocks/Comfort
X
X
X
Distribution of
therapeutic gas
Not adequate, failure,
leak O2 inside chamber
Fire danger, Hyperoxia
X
X
X
Self contained
Breathing
Apparatus (SCBA)
Not available/malfunction/ Operators unable to stay X
Staff not trained in its use. to assist in the
emergency evacuation
of chamber personnel
Malfunction
Vacuum injury/pressure X
loss
X
X
BIBS tracking
regulator
X
CROSS
REF.
5
4
3
4
1
Gas distribution
Panels
Poor design /
Maintenance/ failure
Control panel
Not adequate
(ergonomic), failure,
Control panel
alarms
Lack of function/ settings
to high
Watch systems
and alarms
(passive),
Analyzers, …
Protective systems
(active), Sprinkler
X
X
X
X
X
3, 5
Contamination/ Fire risk
Hypoxia / Poisoning
X
X
X
3, 5
Not adequate, failure,
Lack of function
Contamination/ Fire risk
Hypoxia / Poisoning
X
X
X
3, 5
Not adequate, failure,
Lack of function
Contamination/ Fire risk
Hypoxia / Poisoning
X
X
X
2, 3, 5
Fire extinguishers
Incorrect type
X
X
X
2, 3, 5
Fire suppression
Outside chamber
Lack of function/
Maintenance
Not function at
depth/contaminated
atmosphere
Inability to fight fire
Injury to personnel
X
X
X
2, 3, 5
Fire explosive
hazards
Lack of care in following
standard operating
procedures
Hyper-/ Hypothermia
Fire / Hazards/ Injury
X
X
X
2
May require early
termination of treatment
X
X
3, 4, 5
X
3, 4, 5
Temperature
control
Lack of gas inability to
treat
Incorrect gas/ hypoxia/
poisoning
Positioning, accident
3
Software
Malfunction
Therapy terminated
early
X
Equipment touch
key pads
All come on together with
compression / faulty
Patient vital equipment
inoperable
X
Communications/
Primary
Poor quality
Confusion / Errors /
Panic
X
X
3, 5
Communications/
Secondary
Not functioning
X
X
3, 5
Speakers
Electrical short
Panic / incorrect actions
/ injury / lack of
communications
Sparks / Fire
X
X
Lighting primary
Inadequate
Mistakes at work
X
X
5
Lighting secondary Lack of maintenance
Inability to complete
treatments safely
X
X
5
Ergonomics in and Not adequate
outside the
chamber
Patient Access
Steps / Door widths /
Wheel chair access
Injuries to personnel
X
X
Delays / Lifting / Injury
X
X
X
X
X
3, 5
2, 3, 5
2, 3
2, 3, 4
2
Door
weight/handles
Lack of door stops / doors Injury to personnel
not hung correctly
X
X
X
2, 3, 4
Silencers
Dirty/ Blocked / corroded
Explode / fracture /
Injury
X
X
X
4
Pressure Gauges
Inaccurate
Decompression Illness
X
X
5
Equipment tagging Inadequate/ incorrect
& numbering
Break down / failure
Unable to treat patients
X
X
5
Equipment
charging areas
Electrical shock/ Fire
X
X
X
4
Explosion, Fire, Injury
X
X
X
3, 5
Poor quality of care
X
X
Inability to complete
treatments safely
Inability to complete
treatments safely
Inability to complete
treatments safely
Inability to complete
treatments safely
Accident, safety not
assured
X
X
2, 5
X
X
4
X
X
4
X
X
4, 5
X
5
Accessories
Medical records
Mains electrical
systems
Battery electrical
systems
UPS electrical
systems
Generator
electrical systems
Personal
Fumes/off gassing
Electrical faults
Heat
Not adequate, failure
Incorrect for patient /
Inadequate / not complete
/ up to date /available
Break down/ power cuts/
Not adequate
Hydrogen gas/ insufficient
power / time
Sufficient time/power for
emergency requirements
Not working when
required
No adequate education
X
5
2. Lack of, or inadequate specification for maintenance, including inadequate
specification of post maintenance functional checks,
ITEMS
HAZARDS/ TYPE OF HARM/
P A O CROSS
ERROR
CONSEQUENCES
REF
Safety inspection
Not adequate/
Potentially harmful
X X X
5
regularly
conditions
User manual
Not adequate, (no
Damage, Injury, failure
X X X
5
identification of each
element
Technical
Not adequate
Damage, Injury, failure
X X X
5
Documentation
Compressor
Failure/ lack of regular Contamination/ Injury
X X X
3
filtration system
maintenance
Environmental
Failure/ lack of regular Contamination/ Injury
X X X
4
control unit/ Rain
maintenance
View Ports
Damage /Scratched/
Severe pressure loss
X X X
Out of date
Decompression Illness
Back up machinery Inadequate/ lack off
Break down / failure
X
X
4
Not serviced.
Unable to treat patients
maintained
Patient monitoring
Failure/ lack of regular Inaccurate / injury
X X X
3, 4, 5
maintenance
3
O2 Analyzers/
Primary
O2 Analyzers/
Secondary
CO2 analyzers
CO2 Scrubbers
Door seals/ "O"
rings
Valves needle
Failure cell expired
Inaccurate /
maintenance
As above & Needs to
agree with primary
Failure/ inaccurate
Noise/chemical burns/
corrosion. Electrical
faults.
Damage
Lack of maintenance
Fire suppression
Inside chamber
Tested/function for
hyperbaric
environment
And gas density.
Electrical connection
trip
Power fuses
Bad position / incorrect
Switchboards
rating / faulty trips /
resets
Liquid Oxygen
Position / safe
distances
Cleanliness
Computers & VDU's Failure inside or
outside chamber.
Affected by pressure.
Heat
Unauthorized
Malfunction / Fire.
chamber equipment Contamination /
Electric Shock
Humidity control
Incorrect safe level
Banned equipment / Biggest single causes
Substances inside
of accidents / Fire
Chamber
Patient Lockers
Lack off/ not lockable
Patient Ventilator
Infusion Pumps
Patient Monitoring
Bed/trolley type
Affected by pressure /
density of ambient
pressure
Affected by pressure /
density of ambient
pressure
Affected by pressure /
density of ambient
pressure
Rams/Oil/ pneumatic
Too high PP02
Fire risk
X
X
X
3, 4, 5
Too high PP02
Fire risk
Contamination/ inadequate
flushing/ ventilation/
poisoning
Contamination/ inadequate
flushing/ ventilation/
poisoning
No Compression / loss of
pressure
Lack of compression
/ Supply
Inadequate fire
suppression & electrical
shock
X
X
X
3, 4, 5
X
X
X
3, 4, 5
X
X
X
4
X
X
2, 4, 5
X
X
X
X
2, 3, 5
X
2, 3, 5
X
4
X
2, 3, 5
X
Lack of power for life
support
Injury / off-gassing / Fire
Lack of compression
Inability to treat patients
Inability to finish treatment
Heat/ Fire
Malfunction / Fire.
Contamination / Electric
Shock
Sparks /Fire/
Uncomfortable
Injury / Fire
X
X
X
X
X
4, 5
X
X
X
3, 5
X
X
X
3, 4, 5
X
X
X
X
X
3, 4, 5
Patient inadequately
supplied with drug doses
prescribed
Inaccurate / can not
change settings / failure
X
X
3, 4, 5
X
X
3, 4, 5
Contamination, loss of
height of bed
X
X
Will mean patient will take
banned substances into
chamber/ Fire /
Contamination
Patient inadequately
ventilated
X
3, 4
4
Diabetic monitors
Affected by pressure
Loose Cables/Wires Trapped/
Chaffing/Arching/Fire
3. Inadequate maintenance,
ITEMS
HAZARDS/ TYPE OF
ERROR
User manual
No determination of
each responsibility,
Duties of staff
Personnel unclear of
their duties
Equipment
Break down
maintenance
Equipment
Lack of adequate
documentation
records
Inaccurate
Electrical Shock
HARM/
CONSEQUENCES
Lack of planned
maintenance/ breakdown
Injury/ damage
P
Unable to treat patients
X
Non Return
Valves
Pressure relief
valves
Manifolds
P
HARM/
CONSEQUENCES
Damage, injury
Insufficient size/ faulty
Lack of compression
/ Supply/ Exhaust
Reduced gas flow too
slow compression
Damage to pressure hull
Position / material /
rating / labeling
Incorrect gases supplied /
Injury
Lack of maintenance
X
X
A
A
X
O
3, 4, 5
2
X
CROSS
REF
5
X
X
5
X
X
5
X
5
Lack of planned
maintenance/ breakdown
4. Lack of adequate determination of end of device life,
ITEMS
HAZARDS/ TYPE OF
HARM/
ERROR
CONSEQUENCES
User
Work safety of the facility Damage, injury
manual
5. Loss of mechanical integrity,
ITEMS
HAZARDS/ TYPE OF
ERROR
Mechanical
Work safety of the
elements
facility
Valves 1/4 turn
Lack of maintenance
X
X
O
CROSS REF
X
5
P
A
O
X
X
X
CROSS
REF
2
X
X
X
X
X
4
X
4, 5
6. Inadequate packaging (contamination and/ or deterioration of the device),
ITEMS HAZARDS/ TYPE OF
HARM/
P A O CROSS REF
ERROR
CONSEQUENCES
BIBS
Contaminated/poor
Raised PPO2 in chamber
X X X
fitting/leaking.
Fire risk, Patient not
Breathing resistance
receiving 100% O2
7. Improper re-use
ITEMS
HAZARDS/ TYPE OF
ERROR
Accessories Contamination
HARM/ CONSEQUENCES P
A
Cross infections
X
X
O
CROSS
REF
3, 4
5