BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFV PATIENT CIRCUIT

    MDR report key: 2784981 · Received September 14, 2012

    Report

    Report Number
    1719232-2012-00001
    Event Type
    Malfunction
    Date Received
    September 14, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 14, 2012
    Manufacturer
    BUNNELL
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RRT CALLED TO REPORT THAT TWO CIRCUITS HAD OVERHEATED AND ONE OF THEM HAD MELTED THE HEATER WIRE INSULATION AND CIRCUIT TUBE. BOTH FAILURES OCCURRED WITH THE SAME PT. THE PT WAS NOT COMPROMISED AND CONTINUED TO BE VENTILATED WITH THE SAME HIGH FREQUENCY VENTILATOR (HFV) AND A DIFFERENT PT CIRCUIT. A BUNNELL REP VISITED THE FACILITY ON (B)(4) 2012 AND VISUALLY CONFIRMED THE FAILURE ON ONE CIRCUIT. VISUALLY, THE OTHER CIRCUIT APPEARED INTACT AND UNDAMAGED. THE HIGH FREQUENCY VENTILATOR WAS ALSO CHECKED AND WAS OPERATING NORMALLY. BUNNELL INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST (CAR), NUMBER (B)(4), ON (B)(4) 2012. A SUPPLEMENTAL PMA, P850064/S021, WAS SUBMITTED ON (B)(4) 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 CARE DEPT CALLED TO REPORT THAT TWO CIRCUITS HAD OVERHEATED AND ONE OF THEM HAD MELTED THE HEATER WIRE INSULATION AND CIRCUIT TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HFV PATIENT CIRCUIT CIRCUIT LSZ BUNNELL 902 12E224

    Patients

    Seq Age Sex Outcome Treatment
    1