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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 004 05 22 000
Date submitted: 5/9/2022
Manufacturer:GE Healthcare
Device Type:CARESCAPE R860 Ventilators, and Engström Carestation and Engström PRO Ventilators
Description:Ventilator
Medical Device Identifier:CARESCAPE R860 Ventilators (GTIN) 00840682102346 manufactured on or after April 1, 2019
The following Field Replacement Unit Batteries distributed on or after April 1, 2019 for CARESCAPE R860, Engström Carestation and Engström PRO ventilators:
FRU PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V)
FRU PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR)
Reason of Field Safety Corrective Action:Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Remedy Action:Please refer to “Actions to be taken by Customer/ User” in the attached FSN
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:E3E4C50D5D2F6
SFDA Comments:SFDA urges all healthcare providers that have devices subjected to this safety alert to contact the company.
Attachments: GE Healthcare.pdf