BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM STRETCHER, PRIME X

    MDR report key: 3233935 · Received July 18, 2013

    Report

    Report Number
    0001831750-2013-06453
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONFIRMED THAT THIS COMPLAINT WAS ENTERED IN ERROR AND THAT ALL DEVICES AT THIS ACCOUNT WERE WORKING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    CUSTOMER COULD NOT LOCATE UNIT. RWO CANCELLED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES COULD NOT REMAIN ENGAGED DUE TO BROKEN BRAKE PAD. 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 BRAKES COULD NOT REMAIN ENGAGED DUE TO BROKEN BRAKE PAD. 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
    333500 ZOOM STRETCHER, PRIME X STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1