BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PRO AMBULANCE COT - OBS

    MDR report key: 3820151 · Received May 20, 2014

    Report

    Report Number
    0001831750-2014-02990
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED BY THE STRYKER FIELD SERVICE REPRESENTATIVE. THE FIELD TECHNICIAN WAS UNABLE TO DUPLICATE THE ALLEGED ISSUE. THIS ALLEGED EVENT MAY HAVE BEEN USER ERROR CAUSING A DRIFT EVENT, BASED ON WHAT WAS REPORTED AND DUE TO THE NATURE OF HYDRAULIC SYSTEMS. IT WAS ALSO ALLEGED THAT THE EMS CREW HAD STRAINED THEIR BACKS TRYING TO PREVENT THE COT FROM LOWERING. THE BACK STRAINS DID NOT REQUIRE MEDICAL INTERVENTION. THE FIELD SERVICE REPRESENTATIVE INSTRUCTED THE CUSTOMER ON HOW TO PROPERLY OPERATE THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DROPPED TO THE GROUND WHILE TRANSPORTING A PATIENT. THE EMS AGENTS CLAIM THAT THEY STRAINED THEIR BACKS WHEN TRYING TO PREVENT THE UNIT FROM DROPPING DOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DROPPED TO THE GROUND WHILE TRANSPORTING A PATIENT. THE EMS AGENTS CLAIM THAT THEY STRAINED THEIR BACKS WHEN TRYING TO PREVENT THE UNIT FROM DROPPING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298876 POWER PRO AMBULANCE COT - OBS STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1