BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMANCE PRO AMBULANCE COT

    MDR report key: 1963936 · Received January 12, 2011

    Report

    Report Number
    1831750-2011-00380
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV
    Product Code
    INK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    HEAD SECTION ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT ON THE PATIENT LEFT SIDE, THE LOADING WHEEL AND PLASTIC COVER WERE ABLE TO MOVE LEFT/RIGHT. THIS WAS CAUSED BY A METAL BREAK WHERE TWO SCREWS ATTACH THE WHEEL ASSEMBLY TO THE HEAD SECTION FRAME AT THE SCREW LOCATION. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMANCE PRO AMBULANCE COT STRETCHER, WHEELED INK STRYKER CORP., MEDICAL DIV 6085 NA

    Patients

    Seq Age Sex Outcome Treatment
    1