BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6215209 · Received December 30, 2016

    Report

    Report Number
    2031642-2016-03632
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Report Date
    December 3, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(6).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE BATTERY TO ADDRESS THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED WITH BATTERY FAILURE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866441 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1