Löwenstein Medical · Arzbacher Str. 80 · D-56130 Bad Ems
Medical Device Security
Bad Ems, 2021-04-07
Field Safety Notice to elisa 300, elisa 500, elisa 600, elisa
800 and elisa 800VIT
Dear Sir or Madam,
Quality, safety and customer satisfaction are our top priorities. Therefore, as usual, we
would like to act consistently and transparently and ask for your support in implementing
this Field Safety Notice.
In February 2020 we informed you about the following safety notice. In this notice, we have
announced a new software version. Now we are introducing versions 2.09.4 and 2.04.4 for
the elisa devices. This update resolves all issues described in the Field Safety Notice that
was sent in February 2020.
As a distributor, you now have to consider this:
•
Observe the content of the safety information.
•
Update all devices to 2.04.4 or 2.09.4, depending on the hardware version.
•
Acknowledge receipt of this letter with Appendix A.
•
Confirm each individual update using this link (https://www.hul.de/fsa) or
scan the QR code for each individual serial number in Appendix B.
•
The update deadline is set for September 2021.
Affected Products:
Only software versions SW 2.02.x, 2.04.0, 2.04.1, 2.04.2 and 2.05.x of the intensive care
ventilation elisa 300, elisa 500, elisa 600, elisa 800 and elisa 800VIT are affected by this
malfunction.
Means only units having installed Display in Version 2 (Item 0682000, 0682001)
Displays Version 2 are those ones having the alarm light on the upper side of the display
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Problem description:
The evaluation of various customer complaints has revealed a problem with crashes when
working with the graphical user interface, which leads to a restart of the control unit
(monitor). Under certain circumstances, the screen can be restarted.
Ventilation is continued and maintained with the previous settings.
The possibility of restarting the control unit without impairing ventilation was taken into
account when developing the elisa 300, elisa 500, elisa 600, elisa 800 and elisa 800VIT, but
the calculated probability of occurrence is higher than originally expected.
The automatic restart of the monitor is intended to prevent the loss of monitoring at the
control unit due to communication errors between the ventilator and the control unit.
If communication is disturbed, the ventilation unit forces the operating system of the control
unit to restart. As one element of our security architecture, the ventilation unit continues
ventilation without interruption and, if necessary, provides visual and audible alarms.
•
•
•
•
If only a restart of the control unit has been forced, a short low-priority acoustic and
visual alarm is triggered (using the alarm corners on the ventilation unit, see Figure
1 - point A), see table point 1.
If an alarm was already active at the time of the forced restart of the screen (e.g.
"minute volume high") or a new alarm occurs, the ventilator unit takes over the
visual and audible alarm, see table point 2 and 3.
If the acoustic alarms are muted by pressing the Pause button, the ventilator only
alarms visually for the period of time when the acoustic alarms are inactivated, see
point 4.
In the event of a serious fault in the ventilator, a constant alarm tone sounds and
the alarm corners of the control unit light up permanently in red, see point 5 and
point 6.
Picture 1: Alarm corners ventilation unit
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Possible dangers:
Table 1: Alarm situation during panel reboot
If the control unit restarts while a patient is being ventilated, the ventilation unit continues
the ventilation of the patient. The occurrence of this incident is not visible to the patient.
The severity is considered insignificant, as ventilation is continued without interruption.
Required measures of the customer/user:
Note that an unexpected restart of the control unit may occur:
A problem constellation occurs.
•
The ventilation unit forces a restart of the control unit.
•
The ventilation unit continues ventilation unchanged.
•
The ventilator does not give an audible and visual alarm.
•
Alarms that are already active or that occur are displayed
in this short time via the ventilation unit.
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Identification of the regarding devices:
1. Turn on the ventilator.
2. The software version is displayed in the „Standby-Mode“ and
the system test-screen in the lower left corner, as shown on
the figure.
3. If the displayed software-version is SW 2.02.x, 2.04.0,
2.04.1, 2.04.2 and 2.05.x your ventilator is affected of the
Field Safety Notice.
We apologize for any inconvenience, which may be associated with this Field Safety Notice,
but this Field Safety Notice is necessary to ensure patient safety.
A Löwenstein Medical service technician or one of our service partners will contact you to
schedule the software update.
We thank you for your cooperation. In case you have further questions please do not
hesitate to contact us.
Contact:
If you have any questions, please contact us directly - of course, we will be happy to answer
your questions: If necessary, please contact our Service Team: supportMD@hul.de
Best regards,
Jens Schmidt
Quality Management
Attachment A
Reply to Löwenstein Medical
Attachment B
List of Serial numbers with QR-Code for feedback
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Jörg Marschinke
Product Manager
Appendix A
Reply to Löwenstein Medical
Regarding the FSCA “Elisa 300-600” dated 2021-03-16
The original letter was sent to:
Please return this completed reply form by fax, e-mail or post to:
Fax:
e-mail:
+49 2603 96 00 1890
mps@hul.de
Löwenstein Medical
Qualitätsmanagement
Arzbacher Strasse 80
56130 Bad Ems
Germany
Please complete in block capitals:
 I hereby confirm receipt of this safety information further confirm that I have read and
understood its content. This letter has been brought to the attention of all users of the
product and other people to be informed in my organization.
Where we have passed on these products to third parties, a copy of this letter has
been forwarded to them.
_______________________
Date, signature
_______________________________________
Name (in BLOCK CAPITALS)
_______________________________________
Position (in BLOCK CAPITALS)
_______________________________________
e-mail (in BLOCK CAPITALS)
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Appendix B
List of Serial numbers and device name, that delivered by Löwenstein Medical.
Please note we always recommends, that all devices updated to the latest software version. Please
use our online form to finalize the updates for each device. You can use prefilled QR Code for each
device. Otherwise, you can use the native permanent link https://www.hul.de/fsa.
Pos
SN
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Device Name
Link to online form