BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEXX

    MDR report key: 2508667 · Received March 28, 2012

    Report

    Report Number
    1523574-2012-00005
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 27, 2012
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HINGE MATERIAL WAS VERIFIED WITH ZERO DEFICIENCY. FAILURE ANALYSIS INDICATES LIKELIHOOD OF SUDDEN WEIGHT SHIFT AND/OR UNEVEN WEIGHT DISTRIBUTION.

    Description of Event or Problem · 1

    A (B)(6) PATIENT WAS BEING LIFTED INTO THE AMBULANCE FOR FOUR EMTS WHEN ONE OF THE TWO LOAD FRAME HINGES BROKE. THE STRETCHER WAS THEN LOWERED TO THE GROUND WITH NO INJURIES TO THE EMTS OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEXX POWERFLEXX FPO FERNO-WASHINGTON, INC. 0015729

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK