BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FERNO MILLENNIA 18" BLUE BACKBOARD

    MDR report key: 1653399 · Received March 31, 2010

    Report

    Report Number
    1523574-2010-00002
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    February 22, 2010
    Report Date
    February 1, 2010
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE REQUESTED THE UNIT BE RETURNED FOR FAILURE ANALYSIS. UNIT NOT RETURNED AS OF (B)(4) 2009.

    Description of Event or Problem · 1

    WHILE LOADING PATIENT ONTO BACKBOARD FROM AN AUTOMOBILE, THE BOARD BROKE JUST ABOVE THE HEAD END AT THE HANDLES. THE BACKBOARD WAS BEING HELD APPROXIMATELY 2.5 FEET FROM GROUND AND THE PATIENT WAS LOADED. WHILE THE PATIENT WAS BEING STRAPPED TO BOARD, THE BOARD BROKE. THE PATIENT FELL TO THE GROUND. PATIENT WAS IN A C-COLLAR AT TIME OF INCIDENT. THERE HAS BEEN NO REPORT OF DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FERNO MILLENNIA 18" BLUE BACKBOARD FERNO MILLENNIA 18" BLUE BACKBOARD FPP FERNO-WASHINGTON, INC. MILLENNIA BACK BOARD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK