BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8703745 · Received June 17, 2019

    Report

    Report Number
    2031642-2019-03864
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Report Date
    June 4, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 03SEP2019; B4: 04SEP2019. THE CUSTOMER'S BIOMED CONFIRMED THE FAILED NAV-RING ISSUE. HE STATED THAT THE TOUCHSCREEN WAS FUNCTIONING. THE CUSTOMER'S BIOMED REPORTED THAT THE FRONT BEZEL WAS REPLACED TO ADDRESS THE REPORTED NAV-RING ISSUE. 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

    THE CUSTOMER REPORTED A FAILED NAV-RING. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 17JUNE2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILED NAV-RING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496931 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1