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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 128 03 13 000
Date submitted: 3/24/2013
Manufacturer:MAQUET Cardiovascular LLC
Device Type:Oxygenators, Extracorporeal Membrane, CARDIOHELP-i Systems
Description:
Oxygenators, Extracorporeal Membrane, Pumps, Extracorporeal Perfusion
Medical Device Identifier: All CARDIOHELP devices up to SIN: 90410628 • except SIN: 90410622 and 90410626
Reason of Field Safety Corrective Action:Human Machine Interface May Unexpectedly Shut Down; Pressure Values on Display May Freeze
Remedy Action: MAQUET has updated its current CARDIOHELP-i software to version 3.3.2.0. This new software version shall be installed by an authorized MAQUET service technician.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD, Riyadh, (01) 4041717
Report Source:NCMDR
Source Ref. Number:ABFBC5EB3538B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: MAQUET Cardiovascular LLC.pdf