BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONETIC

    MDR report key: 1202495 · Received October 8, 2008

    Report

    Report Number
    2031702-2008-00190
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    CARDINAL HEALTH 230/PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN WHEN THE SILENCE/RESET BUTTON WAS PRESSED WHILE ON INTERNAL BATTERY. LATER, THE VENTILATOR SHUT DOWN WITHOUT USER INTERVENTION WHILE ON INTERNAL BATTERY. THE VENTILATOR WAS NOT CONNECTED TO A PATIENT WHEN REPORTED PROBLEMS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CARDINAL HEALTH 230/PULMONETIC SYSTEMS, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1