BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION VENTILATOR SYSTEM

    MDR report key: 600796 · Received May 6, 2005

    Report

    Report Number
    3004023066-2005-00005
    Event Type
    Malfunction
    Date Received
    May 6, 2005
    Date of Event
    October 11, 2004
    Report Date
    October 25, 2004
    Manufacturer
    EVENT MEDICAL LTD
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE BY EVENT MEDICAL THERE WAS EVIDENCE OF A DAMAGED GROUND WIRE IN THE AREA WHERE THE DAMAGE TO THE PRINTED CIRCUIT BOARD HAD OCCURRED. AS SUCH AS INADVERTENT POWER TO GROUND SHORT IS DEEMED TO BE THE MOST LIKELY CAUSE OF THE INCIDENT. NO OTHER INCIDENTS OF THIS TYPE HAVE OCCURRED AND IT IS THEREFORE DEEMED TO BE AN ISOLATED INCIDENT AND NO FURTHER ACTION IS REQUIRED. EVENT MEDICAL WILL CONTINUE TO MONITOR FOR INCIDENTS OF THIS NATURE AND CONSIDERS THIS FILE TO BE CLOSED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BURING TO THE INTERNAL PRINTED CIRCUIT BOARD. DURING A VISIT TO THE CUSTOMER SITE IN 2005, AN EVENT MEDICAL SERVICE REPRESENTATIVE INSPECTED THE UNIT. BASED ON THIS EVALUATION, IT WAS DETERMINED THAT A MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRATION VENTILATOR SYSTEM VENTILATOR CBK EVENT MEDICAL LTD INSPIRATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN