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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 046 03 11 000
Date submitted: 3/9/2011
Manufacturer:Medtronic
Device Type:Lucas Chest Compression Systems
Description:Resuscitators, Cardiac
Medical Device Identifier:LUCAS 2 Chest Compression Systems. Serial Nos.: 30090016 through 30101932 Units distributed between April 2009 and December 2010. Serial numbers starting with 30101200 and higher have been observed to be more likely to experience this issue and servicing devices in this serial number range will be prioritized.
Reason of Field Safety Corrective Action:Lucas have been experiencing device malfunctions resulting from the failure of a hood probe on the device that connects to the battery. If the device malfunctions it will stop in fail safe mode and the LEDs will start flickering or the device will switch off.
Remedy Action:Keep LUCAS 2 in service and continue to use it in accordance with the Instructions For Use, described below: Section 3.8 - Safety Precautions. WARNING – MALFUNCTION. If there are interruptions, or the compressions are not sufficient or something unusual occurs during operation: Push ON/OFF for 1 second to stop LUCAS and remove the device. Start manual chest compressions.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD, Riyadh (01) 4041717
Report Source:NCMDR
Source Ref. Number:7D23ABC2D82E5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: 2._KSA_Customer_letter[1].pdf