BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER LOAD

    MDR report key: 3070778 · Received April 22, 2013

    Report

    Report Number
    0001831750-2013-03599
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER LOAD WOULD NOT LOAD THE COT DUE TO DEBRIS BLOCKING THE SYSTEM. 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 POWER LOAD WOULD NOT LOAD THE COT DUE TO DEBRIS BLOCKING THE SYSTEM. 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
    171264 POWER LOAD STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1