BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2140848 · Received May 31, 2011

    Report

    Report Number
    1831750-2011-05324
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: HANDLE WELDMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM DRIVE STARTS AND STOPS WHILE TRAVELING WITH THE PATIENT IN THE BED. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM304 M-SERIES W/ZOOM WHEELED POWERED STRETCHER INK STRYKER MEDICAL 1025 NA

    Patients

    Seq Age Sex Outcome Treatment
    1