BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PRO AMBULANCE COT

    MDR report key: 2981629 · Received February 27, 2013

    Report

    Report Number
    0001831750-2013-01576
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 19, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS FOUND THAT THE COT HAD DAMAGED ELECTRICAL CONTACT PINS THAT WERE NOT ALLOWING THE POWERLOAD SYSTEM TO READ THE ENGAGEMENT OF THE COT. THIS CAUSED THE VISUAL INDICATION LIGHT TO NOT SENSE THAT THE COT WAS SECURED TO THE SYSTEM. IT WAS CONFIRMED THAT THE COT WOULD FASTEN TO THE SYSTEM FOR TRANSPORT EVEN THOUGH THE VISUAL INDICATION SYSTEM WAS NOT FUNCTIONING. THE OPERATIONS/MAINTENANCE MANUAL ALSO STATES TO CHECK THAT THE COT IS SECURED IN THE POWERLOAD SYSTEM BY FIRMLY MOVING THE COT FOOT END BACK AND FORTH TO ENSURE THAT THE COT IS SECURED IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT IS NOT LOCKING INTO THE POWER LOAD SYSTEM DUE TO THE FOOT END FASTENER. FURTHERMORE, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COT IS NOT LOCKING INTO THE POWER LOAD SYSTEM DUE TO THE FOOT END FASTENER. FURTHERMORE, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83368 POWER PRO AMBULANCE COT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1