BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8884520 · Received August 12, 2019

    Report

    Report Number
    2031642-2019-05861
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Report Date
    December 5, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DATE OF REPORT: 12AUG2019. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND CONFIRMED THE REPORTED PROBLEM. THE FSE REPLACED THE FRONT BEZEL TO ADDRESS THE FINDING. THE FSE TESTED THE UNIT; THE UNIT WAS FULLY OPERATIONAL. THE UNIT WAS WITHIN THE MANUFACTURER'S SPECIFICATION AND WAS RETURNED TO SERVICE. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER A REQUEST FROM THE FDA ON MARCH 1, 2019 TO REVIEW COMPLAINTS FROM 29 NOV 2017 TO 29 NOV 2018. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR UNIT'S NAVIGATION RING (NAV-RING) HAD FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679013 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1