BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E500 VENTILATOR

    MDR report key: 1060735 · Received June 11, 2008

    Report

    Report Number
    2023050-2008-00044
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    March 26, 2008
    Report Date
    May 15, 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: PC BOARD WAS RETURNED FOR EVAL. AFTER THE VISUAL INSPECTION AND INTENSIVE INVESTIGATION, IT WAS FOUND THAT R31 AND Q1 WERE OVERHEATED. CONCLUSIONS: A DEFECTIVE BATTERY WITH LOW INTERNAL RESISTANCE STRESSES THE BATTERY CHARGING CIRCUITRY AND CAUSES Q1 TO OVERHEAT AND FAIL AS A SHORT CIRCUIT. ONCE Q1 FAILS, THE REST OF THE CHARGING CIRCUIT CONSISTING OF R31, D70, AND D71 ALSO OVERHEAT AND FAIL AS OPEN CIRCUIT. A REVIEW OF THE MAINTENANCE/SERVICE RECORDS SHOW THAT BATTERY FAILURE ABOVE IS MOST LIKELY TO OCCUR WITH BATTERIES THAT HAVE BEEN IN USE FOR AT LEAST 3 YEARS OR MORE. IN AN EFFORT TO PREVENT THE RECURRENCE OF THIS ISSUE, A CHANGE HAS BEEN MADE TO THE MAINTENANCE SCHEDULE OF THE BATTERY FROM 5 YEARS TO 2 YEARS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THE E500 VENTILATOR DURING USE. THE DISTRIBUTOR'S TECHNICIAN FOUND THAT THE DC-DC BOARD WAS BURNT. PER DISTRIBUTOR, THE UNIT WAS MANUFACTURED IN 2003; HOWEVER, THE PCB1831A AND BATTERY HAD NEVER BEEN REPLACED. ADDITIONAL INFO WAS RECEIVED ON MAY 18, 2008 THAT WHEN THE INCIDENT OCCURRED, THE NURSE IN THE HOSP OPENED THE WINDOW AND CALLED THE HOSPITAL'S MEDICAL ENGINEER. THE UNIT AS REMOVED FROM THE PT, AND THE PT WAS SWITCHED TO ANOTHER VENTILATOR. THERE WAS REPORTEDLY NO ALARM SOUND. PLEASE NOTE THAT THERE WAS NO DEATH OR INJURY IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E500 VENTILATOR VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK