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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 081 04 12 000
Date submitted: 4/21/2012
Manufacturer:Ergolet A/S
Device Type:Bathing & Toileting chair, Ergolet Hera II
Description:Bathing & Toileting chair
Medical Device Identifier:Model number: 041-00250, 041-00255, 041-00256, 041-00280, 041-00281; S/N: 1379 to 2180
Reason of Field Safety Corrective Action:Due to an incident and several claims regarding broken gas springs on the Hera II, and after specific risk analysis, Ergolet has decided that replacement of the gas spring is necessary. The back fixture of the gas spring has been known to break after a significant time of use, resulting in the chair to tilt backwards. If a patient is seated in the chair during this malfunction, there is a risk of the patient hurting the back of the head or getting injured in the neck by the sudden backwards movement.
Remedy Action:The gas spring has been updated with a reinforced back fixture on products with serial number 2181 and higher. The updated gas spring is compatible to all Hera II and can therefore be used for replacement. The gas spring can be mounted by any competent technician by following the instruction in the attached.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:DK-2012-04-18-006
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Ergolet.pdf