X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 042 03 16 000
Date submitted: 3/7/2016
Manufacturer:Stryker
Device Type:PositionPRO Mattress .
Description:PositionPRO is a powered pressure relief support surface with low air loss (LAL)
Medical Device Identifier:Manufacturer Model Number : 2920-000-000 Serial Number(s) : See Attachment Date of Distribution: 01/01/2006 – 12/31/2010
Reason of Field Safety Corrective Action:It was identified through customer complaints that an alleged melting event occurred with the power cord on the PositionPRO surface.
Remedy Action:1. Locate the PositionPROTM surfaces listed by serial number on the attached business reply form.

2. Visually inspect each affected cord.

a. If the plug has bent or cracked prongs, burned plastic, or shows signs of excessive wear, take the surface out of service immediately.

b. If you identify an affected plug that must be removed from service, please call Azza Ibrahim , RAQA Manager MEA , Phone No.: :+971501007354

c. If the cord does not show signs of damage, the surface can remain in service until a replacement cord is available. Users should monitor the power cords regularly for excessive wear and tear and be mindful not to subject the power cords to misuse or abuse.

Always remember to unplug the surface prior to moving the unit and the plug should be unplugged by grabbing the mold near the outlet and pulling the cord in a direction parallel to the floor (not at an angle). As part of this device correction Stryker Medical will be replacing all affected power cords at no cost, so it is not necessary to call Stryker Medical to inform us you have an affected power cord.

3. A Stryker Representative will contact your facility to schedule a time for repair. For other surface replacement options, please, reach out to your Stryker Account Manager.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:E5FC337213299
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Stryker.pdf