BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 1060734 · Received June 11, 2008

    Report

    Report Number
    2023050-2008-00043
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    April 27, 2008
    Report Date
    May 14, 2008
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY ANALYSIS: THE E360 ANALOG BOARD P/N PCB2104A HAD A DEFECTIVE OXYGEN PRESSURE TRANSDUCER (XD103). TEST POINT TP112 SHOULD HAVE MEASURED APPROXIMATELY 2.6 VDC; HOWEVER, IT MEASURED - 0.448 VDC WITH OR WITHOUT PRESSURE APPLIED. CONCLUSION: OXYGEN PRESSURE TRANSDUCER XD103 ON E360 ANALOG BOARD WAS NON OPERATIONAL.

    Description of Event or Problem · 1

    REPORTEDLY, DURING USE ON A PT "O2 SUPPLY LOSS ALARM" WENT OFF EVEN THOUGH THE HOSE WAS CONNECTED CORRECTLY. THIS SYMPTOM OCCURRED THREE TIMES ON THE UNIT. THE REPORTED PROBLEM WAS SOLVED BY THE TECHNICIAN OF THE DISTRIBUTOR BY REPLACING THE TRANSDUCER AT O2 SIDE OF THE ANALOG BOARD TO NEW ONE. AT THE TIME OF THE INCIDENT, THE PT WAS SWITCHED TO MANUAL VENTILATION AND THEN TO ANOTHER VENTILATOR. PLEASE NOTE THAT THERE WAS NO DEATH OR INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR