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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 138 09 12 000
Date submitted: 9/16/2012
Manufacturer:Draeger Medical Inc
Device Type:medical air, Compressed Air System and dryer
Description:Compressed Air System
Medical Device Identifier:EcoPharm Tower MA DME 0125-805
Reason of Field Safety Corrective Action: Increasing numbers of cases in which significant quantities of compressed air escaped during generation of compressed air in the hospital. This was due to a failure of input valves in the EcoPharm Tower absorption dryer. In one case, both redundant dryers failed within 24 hours, resulting in a compressed air shortage warning on the hospital's wards. There has been no report of any failure of medical devices, nor of any personal injury.
Remedy Action: The Instructions for Use (lfU) for compressed air systems stipulates that compressed air systems shall be checked daily for the presence of hissing noises. This reveals clearly if there is a loss of compressed air in one dryer - the second dryer continues to maintain the supply of compressed air. If there is a dryer failure, the Instructions for Use of the EcoPharm Tower stipulates the following in the section "Faults Effect Cause Remedy": "Close valves, turn off dryer and call Drager Service". If the second dryer fails, it additionally states the following: "Attention: If the fault occurs during operation to one dryer, the dryer must be isolated immediately from the electricity supply. Immediate repair necessary". In the assembly section the following is added "Over the fusing it must be able to switch off the machine. Disconnecting the device from the power supply results in closure of the output valve. This prevents further air from being discharged and ensures that compressed and filtered air is supplied to the hospital. In order to detect a dryer failure at an early stage and therefore be able to arrange for a prompt repair, we urgently recommend that you reduce the inspection interval to every 12 hours. In cooperation with the manufacturer of the EcoPharm Tower, we are working hard to improve the product's reliability.
Athorized Representative/Importer/Distributor:International Medical Development Co. Ltd. Riyadh (01)4623000
Report Source:NCMDR
Source Ref. Number:07830142A216F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments