BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM STRETCHER CONFIGS -OBS2010

    MDR report key: 2963758 · Received February 15, 2013

    Report

    Report Number
    0001831750-2013-01197
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRAKES WOULD NOT HOLD DUE TO BENT BRAKE RINGS. ALONG WITH THE DAMAGE TO THE BRAKE RING WELDMENT, THE EXTENSION SPRINGS AND BRAKE CUSHIONS, ON THE BRAKE RINGS, WERE DAMAGED. THESE DEFECTS WERE COSMETIC DAMAGE AND WOULD NOT AFFECT BRAKING FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE STRETCHER WAS DRIFTING WHILE THE BRAKES WERE ENGAGED. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT THE BRAKES COULD NOT BE ENGAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CUSTOMER ALLEGED THAT THE STRETCHER WAS DRIFTING WHILE THE BRAKES WERE ENGAGED. UPON INSPECTION OF THE UNIT BY THE SERVICE TECHNICIAN, IT WAS IDENTIFIED THAT THE BRAKES COULD NOT BE ENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68123 OEM STRETCHER CONFIGS -OBS2010 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO 0722

    Patients

    Seq Age Sex Outcome Treatment
    1