BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFV PATIENT CIRCUIT

    MDR report key: 2784982 · Received September 14, 2012

    Report

    Report Number
    1719232-2012-00002
    Event Type
    Malfunction
    Date Received
    September 14, 2012
    Date of Event
    June 13, 2012
    Report Date
    September 14, 2012
    Manufacturer
    BUNNELL
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CIRCUIT WAS RETURNED AND AN EVAL IS UNDERWAY. A BUNNELL REP VISITED THE FACILITY ON 08-15-2012. IT WAS NOTED THE PT BOX (WHICH CONTAINS THE PT CIRCUIT), WAS LOCATED DIRECTLY IN FROM OF AN HVAC RETURN AIR REGISTER. THIS PLACEMENT COULD CONTRIBUTE TO THE FAILURE OF THE PT CIRCUIT AND IS BEING INCLUDED IN THE FAILURE INVESTIGATION. BUNNELL INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST (CAR), NUMBER 12-2, ON 09-14-2012. A SUPPLEMENTAL PMA, P850064/S021, WAS SUBMITTED ON 09-06-2012 TO INCREASE THE HEATER WIRE INSULATION TEMP RATING, WHICH WILL SIGNIFICANTLY REDUCE THE PROBABILITY OF THIS TYPE OF RARE FAILURE OCCURRING. ADDITIONAL INFO RECEIVED FROM THE FACILITY, FAILURE INVESTIGATION OR FROM THE CAR WILL BE ADDED TO THIS REPORT.

    Description of Event or Problem · 1

    RESPIRATORY THERAPY DEPT SUPERVISOR CALLED TO REPORT THAT A CIRCUIT HAD ¿SPARKED¿ IN THE CIRCUIT TUBING. THE HIGH FREQUENCY VENTILATOR AND PT CIRCUIT WAS ON A PT AT THE TIME. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HFV PATIENT CIRCUIT CIRCUIT LSZ BUNNELL 902 12E211

    Patients

    Seq Age Sex Outcome Treatment
    1