BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOAD

    MDR report key: 3212499 · Received July 9, 2013

    Report

    Report Number
    0001831750-2013-06164
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT FRAGMENTS WERE LODGED IN THE TRANSFER CAUSING THE POWERLOAD SYSTEM TO GET STUCK AND NO LONGER ABLE TO UNLOAD THE COT.

    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 RELEASE ARM WAS BROKEN WHICH COULD AFFECT LOADING AND UNLOADING OF THE COT. 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 THAT THE RELEASE ARM WAS BROKEN WHICH COULD AFFECT LOADING AND UNLOADING OF THE COT. 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 THAT THE RELEASE ARM WAS BROKEN WHICH COULD AFFECT LOADING AND UNLOADING OF THE COT. 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
    314408 POWER LOAD STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1