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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 082 05 13 000
Date submitted: 5/21/2013
Manufacturer:Arjo Huntleigh
Device Type:Integrated bathing system, Alenti
Description:Part of an integrated bathing system, Alenti™ provides transport and transfer solution for semi-dependent residents.
Medical Device Identifier:SN : CDB8003-01, CDB8053-01, CDB8103-01, CDB8153-01
Reason of Field Safety Corrective Action:The manufacturer conducted Field Safety Correction Actions in Canada between 2004 and 2007 to provide improved safety instructions and warnings to reduce the risk of the Alenti chair tipping and patient falls. The incident rate has since declined. However, the manufacturer continues to receive several incident reports in Canada each year. Since August 2012, there have been nine tipping and patient slide-out incidents reported in Canada. Two of these were associated with patient deaths ( More details in attached file )
Remedy Action:Read the precautions well and must be observed at all times when operating the Alenti. Failure to observe these precautions and failure to strictly follow the Instructions for use can cause serious patient injury. (the precaution and instruction with full details in attached file).
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (011 ) 2119948
Report Source:NCAR
Source Ref. Number:CA-2013-05-15-010
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: CA-2013-05-15-010 Alenti Chair_NtH ENGLISH - signed.pdf