BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM STRETCHER,30"LITTER

    MDR report key: 3140283 · Received May 31, 2013

    Report

    Report Number
    0001831750-2013-04935
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 5, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ZOOM DRIVE WAS INTERMITTENT DUE TO LOOSE ZOOM HANDLES. HOWEVER, THE STRETCHER WAS STILL MOBILE MANUALLY. ADDITIONALLY, IT WAS ALLEGED THAT THE IV POLE COULD FALL IN AN UNINTENDED DIRECTION DUE TO A LOOSE IV POLE SOCKET. 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
    241306 PRIME ZOOM STRETCHER,30"LITTER STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO 1125000030

    Patients

    Seq Age Sex Outcome Treatment
    1