BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PRO AMBULANCE COT

    MDR report key: 3211697 · Received July 8, 2013

    Report

    Report Number
    0001831750-2013-06149
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INVESTIGATION, THE LEVEL 1 ROOT CAUSE FOR THE SMOKE EMITTED FROM THE FOOT END WAS A MELTED BATTERY, TERMINAL BLOCK, AND CONNECTORS. BASED ON PREVIOUS INVESTIGATIONS A POTENTIAL LEVEL 2 ROOT CAUSE FOR THE MELTED COMPONENTS COULD BE ATTRIBUTED TO WIRES TO THE TERMINAL BLOCK CROSSING OR POSSIBLY ABNORMAL HIGH USE RESULTING IN EXCEEDING THE EXPECTED DUTY CYCLE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE COT STARTED TO SMOKE WHILE IN USE. 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 VIA REPAIR WORK ORDER THAT THE COT STARTED TO SMOKE WHILE IN USE. 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
    308624 POWER PRO AMBULANCE COT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1