BEUDAMED
    FDA Adverse Event Death Summary report: N

    V60 VENTILATOR

    MDR report key: 5055778 · Received September 4, 2015

    Report

    Report Number
    2031642-2015-01719
    Event Type
    Death
    Date Received
    September 4, 2015
    Date of Event
    July 3, 2015
    Report Date
    August 6, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT DID NOT CONTRIBUTE TO THE PATIENT DEATH. THE ALARM FUNCTIONED AS EXPECTED. THE ISSUE WAS THE VOLUME WAS SET TOO LOW("2") AND WAS INAUDIBLE OUTSIDE THE ROOM. NO MALFUNCTION IDENTIFIED WITH THE VENTILATOR. THE CUSTOMER MADE INTERNAL CHANGES AND NEW POLICIES AND TRAINING ON HOW TO SET ALARMS TO PREVENT ANY FUTURE ISSUES OCCURRING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PATIENT DISCONNECT THE ALARM WAS NOT HEARD OUTSIDE THE PATIENT ROOM. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586853 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death