BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E360 VENTILATOR

    MDR report key: 5091067 · Received September 21, 2015

    Report

    Report Number
    2023050-2015-00217
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 24, 2015
    Report Date
    December 20, 2017
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC
    Product Code
    CBK
    PMA / PMN Number
    K053502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) EVALUATED THE VENTILATOR, AND CONFIRMED THE BATTERY MALFUNCTION. THE CSE OBSERVED THAT THE VOLTAGE INCREASED WHEN IT WAS PLUGGED INTO THE AC POWER SOURCE. THE BATTERY WAS REPLACED TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). A THIRD PARTY SERVICE PROVIDER REPLACED THE BATTERY. THE BATTERY WAS RETURNED FOR EVALUATION. THE SERVICE ENGINEER EVALUATED THE BATTERY AND VERIFIED THE REPORTED COMPLAINT. THE BATTERY WAS PLACED INTO TEST STATION AND IT FAILED THE 10 HOUR DISCHARGE TEST. BATTERY CAPACITY WAS MEASURED AT 0.7% OF THE RATED CAPACITY. THE REPORTED MALFUNCTION WAS DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND THE REPORTED ISSUE WAS ISOLATED TO AN ISSUE WITH THE POWER SOURCE FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MAINTENANCE, AFTER UNPLUGGING THE VENTILATOR, A "LOW BATTERY" ALARM WAS GENERATED AFTER THIRTY SECONDS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623506 E360 VENTILATOR CONTINUOUS VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC E360

    Patients

    Seq Age Sex Outcome Treatment
    1