BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SERIES 26

    MDR report key: 2873643 · Received November 14, 2012

    Report

    Report Number
    1831750-2012-11798
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CUSTOMER NOTIFIED TECHNICAL SUPPORT THAT THE SIDE RAIL COULD NOT REMAIN LATCHED DUE TO A BROKEN WELD. SHARP EDGES WERE ALSO ALLEGEDLY EXPOSED AS A RESULT OF THIS CONDITION. IT WAS REPORTED THAT THERE WAS NO PT INVOLVEMENT, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE SERIES 26 HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1