BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6099869 · Received November 14, 2016

    Report

    Report Number
    2031642-2016-03093
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Report Date
    October 24, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PATIENT INFORMATION AND EVENT DATE WERE REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPLACED THE POWER MANAGEMENT TO ADDRESS THE REPORTED ISSUE. FAILURE ANALYSIS ON THE RETURNED POWER MANAGEMENT BOARD SHOWS THAT THE POWER MANAGEMENT (PM) PCBA WAS TESTED AND NO FAILURES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED WITH BATTERY FAILED MESSAGE. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON PATIENT, BUT THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749622 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1