BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM STRETCHER

    MDR report key: 2914864 · Received December 7, 2012

    Report

    Report Number
    1831750-2012-12656
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE RIGHT AND LEFT ZOOM DRIVE CONTROL HANDLES WERE BROKEN OFF RESULTING IN BARE WIRES BEING EXPOSED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIME ZOOM STRETCHER POWER WHEELED STRETCHER INK STRYKER MEDICAL 1125000030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1