BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFV PATIENT CIRCUIT

    MDR report key: 2784972 · Received September 14, 2012

    Report

    Report Number
    1719232-2012-00003
    Event Type
    Malfunction
    Date Received
    September 14, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 14, 2012
    Manufacturer
    BUNNELL
    Product Code
    LSZ
    PMA / PMN Number
    P850064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMED DEPT CALLED TO REPORT THAT A CIRCUIT HAD ¿SPARKED¿ AND WIRE INSULATION MELTED. THE HIGH FREQUENCY VENTILATOR AND PT CIRCUIT WAS ON A PT AT THE TIME. THERE WAS NO INJURY TO THE PT. 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

    BIOMED DEPT CALLED TO REPORT THAT A CIRCUIT HAD ¿SPARKED¿ AND WIRE INSULATION MELTED. 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 12D129

    Patients

    Seq Age Sex Outcome Treatment
    1