BEUDAMED
    FDA Adverse Event Other Summary report: N

    3003135857-2008-00047

    MDR report key: 1240645 · Received August 29, 2008

    Report

    Report Number
    3003135857-2008-00047
    Event Type
    Other
    Date Received
    August 29, 2008
    Product Code
    CBK
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE REPORTED INCIDENT WAS CONFIRMED. THE REPORTED FAILURE WAS DUE TO: AN IMPROPERLY PLACED FERRITE ON THE POWER CORD PREVENTING THE CONNECTOR FROM BEING FULLY SEATED THEREBY CAUSING AN INTERMITTENT AC CONNECTION AND, AN AGED, LOW CAPACITANCE BATTERY THAT FAILED TO SUSTAIN VOLTAGE DURING THE VENTILATOR'S SHUTDOWN SEQUENCE PREVENTING CERTAIN INFO FROM BEING LOGGED TO MEMORY. THEREFORE, THE NEXT TIME THE VENTILATOR WAS POWERED ON, A "SYSTEM ERROR" MESSAGE WAS DISPLAYED. THE VENT IS DUE FOR AN ANNUAL PM AND THE BATTERY HAS BEEN REPLACED. THE FERRITE WAS MOVED TO ENSURE A PROPER POWER CORD CONNECTION. THE DAMAGED BATTERY CABLE WAS REPLACED. AN OVP, FULL CALIBRATION AND BATTERY TEST WAS PERFORMED AND THE VENTILATOR OPERATES TO THE REQUIRED SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBK

    Patients

    Seq Age Sex Outcome Treatment
    1