BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWPORT MEDICAL INSTRUMENTS, INC.

    MDR report key: 6573497 · Received May 17, 2017

    Report

    Report Number
    2023050-2017-05296
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 5, 2017
    Report Date
    April 5, 2017
    Manufacturer
    COSTA MESA MFG DC
    Product Code
    CBK
    UDI-DI
    10884521542044
    PMA / PMN Number
    K090888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HT70 VENTILATOR GENERATED A REPLACE BACKUP BATTERY ALARM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE VENTILATOR WAS EVALUATED BY A THIRD PARTY SERVICE ENGINEER AND THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. TO RESOLVE THE ISSUE, THE CONTROL BOARD WAS REPLACED. THE VENTILATOR WORKS NORMALLY. REPAIR WAS COMPLETED AT A NON-MEDTRONIC LOCATION AND THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353588 NEWPORT MEDICAL INSTRUMENTS, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK COSTA MESA MFG DC HT70 10884521542044

    Patients

    Seq Age Sex Outcome Treatment
    1