BEUDAMED
    FDA Adverse Event Death Summary report: N

    V60 VENTILATOR

    MDR report key: 6113132 · Received November 18, 2016

    Report

    Report Number
    2031642-2016-03138
    Event Type
    Death
    Date Received
    November 18, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 24, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THE UNIT DID NOT CONTRIBUTE TO THE PATIENT DEATH. THE FIELD SERVICE ENGINEER (FSE) WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE REPLACED THE DATA ACQUISITION TO MOTOR CONTROLLER CABLE TO ADDRESS THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE TRANSPORTING A PATIENT, THE UNIT FAILED WITH A VENT IN-OP CONDITION. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762815 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR