BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE HIGH FREQUENCY VENTILATOR

    MDR report key: 310043 · Received December 19, 2000

    Report

    Report Number
    1719232-2000-00009
    Event Type
    Malfunction
    Date Received
    December 19, 2000
    Date of Event
    October 13, 2000
    Report Date
    December 18, 2000
    Manufacturer
    BUNNELL INCORPORATED
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR WENT DOWN WHILE ON A PT. NO HARM OR INJURY TO PT. NOTE: INSPECTION OF UNIT WAS PERFORMED BY CLINICAL ENGINEERING AT THE USER FACILITY. DISCOVERED THAT THE "TVS" ASSEMBLY HAD FAILED. DEVICE WAS REPLACED WITH ANOTHER UNIT AT THE USER FACILITY. DATE OF EVENT WAS 2000. HOWEVER, THE DEVICE WAS NOT RETURNED AND CO DID NOT RECEIVE ADEQUATE INFO UNTIL RECENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE HIGH FREQUENCY VENTILATOR VENTILATOR LSZ BUNNELL INCORPORATED 203 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN