التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

Datascope/Getinge has developed a solution to address this potential issue. Three (3) hardware kits will be released to update the Cardiosave IABP Hospital Cart, IABP Display, and to provide one (1) updated Transport Protective Cover for the system when used in Rescue/Transport configuration.
When the FSCA Kits are made available, a Datascope/Getinge service Representative will contact your facility to schedule a service event for IABP FSCA upgrade kit installation to protect the Cardiosave Hybrid and/or Rescue IABP(s) from fluid ingress.

Education and training materials will be made available at the link below (QR Code in the attachment) to provide instructions on how to install the Transport Protective Cover onto the Cardiosave IABP system. Getinge will provide one (1) single-use disposable Transport Protective Cover per Cardiosave IABP during the service event.
https://fs7.formsite.com/MedicalAffairs/s94juj9zlb/index. 

In the meantime, please continue to follow the IFU and adhere to the instructions in the attachment "Actions to be taken by the User" when using the Cardiosave Hybrid and/or Rescue IABP.

Manufacturer's Action: Instructions and Correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-16-09-25-1056