BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM304 M-SERIES W/ZOOM

    MDR report key: 2141419 · Received June 1, 2011

    Report

    Report Number
    1831750-2011-05379
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULT: CAM BRACKET ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE STRETCHER KEEPS KICKING OUT OF ZOOM DRIVE. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1