BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOAD

    MDR report key: 3102763 · Received May 9, 2013

    Report

    Report Number
    0001831750-2013-04201
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SERVICE REPORT THAT THE COT WOULD NOT RELEASE FROM THE POWER LOAD SYSTEM DUE TO AN ANCHOR ACTUATOR PIN THAT WAS NOT ENGAGING WITH THE RELEASE ARM. THIS WAS DUE TO A SOCKET HEAD CAP SCREW THAT WAS TOO TIGHT. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204553 POWER LOAD STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1