BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SERIES 29 OBS10/04

    MDR report key: 3172688 · Received June 17, 2013

    Report

    Report Number
    0001831750-2013-05469
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE SIDE RAIL WILL NOT LATCH PROPERLY DUE TO A MISSING EXTENSION SPRING. IN THIS MODEL'S DESIGN OF THE LATCH ASSEMBLY, THE EXTENSION SPRINGS ASSISTS IN THE LATCHING OF THE SIDE RAIL; HOWEVER, THE SIDE RAILS CAN STILL LATCH PROPERLY WITHOUT THE EXTENSION SPRINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL WILL NOT LATCH PROPERLY DUE TO A MISSING COMPRESSION SPRING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL WILL NOT LATCH PROPERLY DUE TO A MISSING COMPRESSION SPRING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274153 ADVANTAGE SERIES 29 OBS10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1