BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION INFANT VENTILATOR

    MDR report key: 1873430 · Received October 18, 2010

    Report

    Report Number
    3003638180-2010-00003
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 11, 2010
    Manufacturer
    EVENT MEDICAL LTD
    Product Code
    CBK
    PMA / PMN Number
    K072590
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ITEM NOT YET RETURNED FOR EVAL AS OF REPORT DATE.

    Description of Event or Problem · 1

    VENTILATOR STOPPED VENTILATING WITH A CONTINUOUS ALARM, THEN SCREEN WAS WHITE AND WAS RELEASED THE EVENT LOGO. "AFTER ATTEMPTING TO RUN THE SELF TEST, BUT FAILED, STAYING THE SCREEN WITH THE LOGO AND FULL BAR OF SELF TEST." PT WAS PLACED ON ANOTHER VENTILATOR; NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRATION INFANT VENTILATOR CONTINUOUS VENTILATOR CBK EVENT MEDICAL LTD LS INFANT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention