BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8785798 · Received July 12, 2019

    Report

    Report Number
    2031642-2019-04495
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Report Date
    June 27, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 01OCT2019 B4: 01OCT2019 THE MANUFACTURER¿S SERVICE TECHNICIAN CONFIRMED THE REPORTED NAV RING ISSUE. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE NAV RING TO ADDRESS THE REPORTED PROBLEM. THE UNIT WAS CHECKED OVERALL, RUN IN TESTED, CLEANED AND FUNCTIONALLY TESTED AND NO ABNORMALITY WAS CONFIRMED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    NAV RING FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 11JULY2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETE.

    Description of Event or Problem · 1

    NAV RING FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580732 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1