BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOAD

    MDR report key: 2931878 · Received January 28, 2013

    Report

    Report Number
    0001831750-2013-00448
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: RELEASE ARM.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF A HEALTH RISK ASSESSMENT PROVIDED BY A HEALTHCARE PROFESSIONAL, THIS ISSUE IF REPEATED IS NOT LIKELY TO RESULT IN SERIOUS INJURY OR DEATH TO THE PATIENT OR CAREGIVER. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT WILL NOT LOCK IN PLACE ON THE POWER LOAD DUE TO A BROKEN RELEASE ARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT WILL NOT LOCK IN PLACE ON THE POWER LOAD DUE TO A BROKEN RELEASE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37847 POWER LOAD STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1