BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEBIG WHEEL ELECT STRETCHER

    MDR report key: 2992796 · Received March 7, 2013

    Report

    Report Number
    0001831750-2013-01847
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 12, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT THE SIDE CONTROL PEDAL WAS FUNCTIONING INTERMITTENTLY. THE REPAIR TECHNICIAN REPORTED THAT THE STRETCHER WOULD NOT RAISE UP WHEN PRESSING THE PEDAL ELECTRICALLY HOWEVER THE STRETCHER COULD BE RAISED MANUALLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE JACK COULD NOT PUMP UP. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE JACK COULD NOT PUMP UP. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97580 PRIMEBIG WHEEL ELECT STRETCHER STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1