BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6204274 · Received December 26, 2016

    Report

    Report Number
    2031642-2016-03565
    Event Type
    Malfunction
    Date Received
    December 26, 2016
    Report Date
    January 25, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FAILURE INVESTIGATION ENGINEER REPORTED THAT DURING REVIEW OF THE DIAGNOSTIC REPORT (DRPT) FOUND THAT THE UNIT ALARMED WITH PRIMARY ALARM FAILED OCCURRENCE. THE FAILURE INVESTIGATION ENGINEER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853883 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1