BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FERNO 35X ANBULANCE STRETCHER

    MDR report key: 1232694 · Received November 14, 2008

    Report

    Report Number
    1523574-2008-00013
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    September 23, 2008
    Report Date
    November 13, 2008
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S FAILURE ANALYSIS CONCLUDED LACK OF DEVICE MAINTENANCE CONTRIBUTED TO THIS EVENT. THE COMPONENT FAILED BECAUSE IT WAS NOT PROPERLY MAINTAINED. THERE WAS NO DESIGN FAILURE. NO CORRECTIVE ACTION REQUIRED. UNIT WILL BE REPAIRED AND RETURNED.

    Description of Event or Problem · 1

    STRETCHER WHEEL FELL OFF WHILE EMTS WERE REMOVING THE STRETCHER FROM THE AMBULANCE. COT BEGAN TO TIP TO ONE SIDE BUT WAS ASSISTED TO THE GROUND BY EMTS. PATIENT STRUCK HER HAND ON THE GROUND AND COMPLAINED OF RIGHT WRIST AND HAND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FERNO 35X ANBULANCE STRETCHER FERNO 35X AMBULANCE STRETCHER FPO FERNO-WASHINGTON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention