TRUMPF Medizin Systeme GmbH + Co. KG Postfach 24 44  07318 Saalfeld  Germany TRUMPF Medizin Systeme GmbH + Co. KG Carl‐Zeiss‐Straße 7‐9 07318 Saalfeld Phone +49 3671 586‐0 Fax +49 3671 586‐41105 info@trumpfmedical.com www.trumpfmedical.com Your contact Phone extension Fax extension E‐Mail Date
+49 3671 586 41 487 med‐service@trumpfmedical.com Februar 2016 FSCA Ref. No: Trumpf9 Urgent Field Safety Information Device Modification concerning Patient transport Shuttle with Trendelenburg fast adjustment function Dear Customer: Within the framework of our product monitoring, we consider it our responsibility to inform you of the risks for patients which could arise when using: Product Material Number Serial Number Range Shuttle 2.7 1254362 100165686 – 101349420 Shuttle 3.7 1254363 100165686 – 101360684 Shuttle 2.7 360 1459862 100165686 – 101368492 Shuttle 3.7 360 1459863 100165686 – 101373756 Description of the problem: Trumpf Medical has received three complaints describing patient transport Shuttles moving to the full Trendelenburg or Anti‐Trendelenburg position without warning to the user. The complaints occurred during surgical preparation or patient transport and have not been involved with any reported injuries. The investigation of this issue has determined that Shuttles within the serial number range listed above have the potential for the locking (fast adjustment) assembly to break, which, if undetected, can allow the table top to tilt to the Trendelenburg or Anti‐Trendelenburg position without warning to the user. The patient is able to slide off the table top. Versions of the Shuttle not listed above are not affected by this potential failure. www.trumpfmedical.com TRUMPF Medizin Systeme GmbH + Co. KG, Sitz Saalfeld, Amtsgericht Jena HRA 502248 Unlimited Liability Partner: TRUMPF Medizin Systeme Beteiligungs‐GmbH, Puchheim, Amtsgericht München HRB 139265 Managing Board: Simone Faath, Taylor Smith Actions to be taken 1. Only use the shuttle for transport of the patient. Ensure that the patient is attended by two people while the shuttle is in use. 2. Trumpf Medical, or a designated service representative, will schedule an appointment with the customer to perform service on the impacted device to prevent the issue from occurring. Passing along this information: Please make sure that, in your organization, all users of the patient transport Shuttle as well as any other personnel who must be informed, have been made aware of this safety information. If you have provided the device to third parties, please forward them a copy of this letter, or inform the contact person listed above. Please store this information at least until this measure has been completed. Confirmation of receipt: Please confirm that you have received this Urgent Safety Information by sending back the completed form listed in Attachment 1. The on‐time return will stop you from receiving further letters on this issue. We highly recommend executing these measures to guarantee patient safety and we ask for your understanding. Best Regards, Trumpf Medical Attachment Attachment 1: Confirmation of Receipt www.trumpfmedical.com TRUMPF Medizin Systeme GmbH + Co. KG, Sitz Saalfeld, Amtsgericht Jena HRA 502248 Unlimited Liability Partner: TRUMPF Medizin Systeme Beteiligungs‐GmbH, Puchheim, Amtsgericht München HRB 139265 Managing Board: Simone Faath, Taylor Smith Attachment 1 (Urgent Safety Information / FSCA Ref. No: Trumpf9) Device Modification concerning Patient transport Shuttle with Trendelenburg fast adjustment function Please return this confirmation within 1 week after receiving the safety information to: Fax: +49 3671 586 41 487 Email: med‐service@trumpfmedical.com Subject: Shuttle (Trumpf9) Please enter your address here: With your signature, you acknowledge that you have received the Urgent Safety Information and understand the risk. Name / Position: __________________________________________________________________ Telephone: _____________________________ Email: ___________________________________ Date: _________________________ Signature: ________________________________________ www.trumpfmedical.com TRUMPF Medizin Systeme GmbH + Co. KG, Sitz Saalfeld, Amtsgericht Jena HRA 502248 Unlimited Liability Partner: TRUMPF Medizin Systeme Beteiligungs‐GmbH, Puchheim, Amtsgericht München HRB 139265 Managing Board: Simone Faath, Taylor Smith