BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOAD

    MDR report key: 3000771 · Received March 12, 2013

    Report

    Report Number
    0001831750-2013-01965
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE RELEASE ARM COVER WAS BROKEN AND AFFECTING THE OPERATION OF THE POWER LOAD SYSTEM. THIS WAS REPORTED IN ERROR, THE RELEASE ARM COVER IS A COSMETIC COVER THAT DOES NOT DISRUPT FUNCTIONALITY OF THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE POWER LOAD SYSTEM WAS NOT WORKING CORRECTLY DUE TO BROKEN RELEASE ARM AND ROUTING TRAY. 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 POWER LOAD SYSTEM WAS NOT WORKING CORRECTLY DUE TO BROKEN RELEASE ARM AND ROUTING TRAY. 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 POWER LOAD SYSTEM WAS NOT WORKING CORRECTLY DUE TO BROKEN RELEASE ARM, COVER, AND ROUTING TRAY. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103729 POWER LOAD STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1