BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM

    MDR report key: 2862014 · Received October 31, 2012

    Report

    Report Number
    1831750-2012-11419
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION IS ONGOING. IF ADD'L INFO IS RECEIVED, A F/U REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZOOM FUNCTION ON THE STRETCHER HAD ALLEGEDLY MALFUNCTIONED. INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIME ZOOM POWERED WHEELED STRETCHER INK STRYKER MEDICAL 1125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1