BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRON DVT

    MDR report key: 154274 · Received March 6, 1998

    Report

    Report Number
    MW1013111
    Event Type
    Malfunction
    Date Received
    March 6, 1998
    Date of Event
    March 2, 1998
    Report Date
    March 2, 1998
    Manufacturer
    HUNTLEIGH HEALTHCARE,INC
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AC POWER SWITCHES ON THESE UNITS ARE EXTREMELY SUSCEPTIBLE TO BREAKAGE. FACILITY HAS LITERALLY REPLACED DOZENS OF THESE SWITCHES ON AN ONGOING BASIS. WHEN SWITCH BREAKS, GREEN PLASTIC 'ROCKER' ELEMENT FREQUENTLY FALLS OUT EXPOSING LIVE AC CONNECTIONS A POTENTIAL SHOCK HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTRON DVT PNEUMATIC COMPRESSION DEVICE JOW HUNTLEIGH HEALTHCARE,INC AC-500 LOTS/SERIAL NO'S)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other