BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 552036 · Received April 14, 2004

    Report

    Report Number
    2031702-2004-00065
    Event Type
    Malfunction
    Date Received
    April 14, 2004
    Date of Event
    March 15, 2004
    Report Date
    April 14, 2004
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE WOULD POWER ON FOR 1 SEC (OR LESS) BEEP AND SHUT DOWN - NOT ON LONG ENOUGH TO SHOW A MESSAGE. OCCURRED SEVERAL TIMES ON ALL POWER SOURCES (DID NOT TRY CIG ADAP). EVENT DATE 2004 AT 9:30AM. CAREGIVER TURNED UNIT ON BEFORE HOOKING UP TO PT. UNABLE TO SUCCESSFULLY POWER VENT UP. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK PULMONETIC SYSTEMS, INC. LTV 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other