BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 6991586 · Received October 31, 2017

    Report

    Report Number
    2031642-2017-03438
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 30, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS WERE MADE FOR FOLLOW-UP INFORMATION ON THE DEVICE AND THE PATIENT OUTCOME AND THE CUSTOMER HAS NOT RESPONDED. IF FURTHER INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE SERIAL NUMBER WAS NOT PROVIDED PHONE NUMBER NOT PROVIDED . A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA MEDWATCH (B)(4) THAT A V60 VENTILATOR WENT INOPERATIVE AND STOPPED DELIVERING PRESSURES.THE PATIENT WAS ON BIPAP AND BEING PREPPED FOR INTUBATION WHEN THE VENTILATOR WENT INOPERATIVE AND STOPPED DELIVERING PRESSURES. THE VENTILATOR WAS REMOVED IMMEDIATELY AND GIVEN FIO2 100% THROUGH A NON-REBREATHING MASK. THE SATURATIONS WERE 100%, RESPIRATORY RATE 18 AND HEART RATE 74.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770870 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention