BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUSSIONAIRE VDR4

    MDR report key: 2749634 · Received September 10, 2012

    Report

    Report Number
    2749634
    Event Type
    Malfunction
    Date Received
    September 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    PERCUSSIONAIRE CORPORATION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PERCUSSIONAIRE VDR4 VENTILATOR HAS ON GOING MULTIPLE PROBLEMS. WHILE IN USE THE MONITRON (MONITOR) WILL GO BLANK MAKING IT IMPOSSIBLE TO MEASURE THE VENT PRESSURES. UNIT HAS COME BACK FROM SERVICE AND NOT BEEN WITHIN SPECS. AIR/O2 BLENDER HAS BEEN UP TO 25% OFF. TECH SUPPORT HARD TO CONTACT. WE HAVE TWO VDR4'S HERE AND USUALLY ONLY ONE IS AVAILABLE FOR USE. THIS IS A GREAT VENTILATOR WHEN IT WORKS PROPERLY BUT IT IS UNRELIABLE. TO MY KNOWLEDGE NO PATIENTS HAVE BEEN HARMED JUST THIS VENT HAS MULTIPLE PROBLEMS THAT DON'T SEEM TO GET FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUSSIONAIRE VDR4 VENTILATOR, CONTINUOUS, FACILITY USE CBK PERCUSSIONAIRE CORPORATION VDR4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *