BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5650728 · Received May 12, 2016

    Report

    Report Number
    2031642-2016-01158
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Report Date
    June 9, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE FAILURE INVESTIGATION ENGINEER (FIE) REPORTED THAT DURING REVIEW OF THE DIAGNOSTIC REPORT (DRPT) IT WAS NOTED THAT THERE WERE SEVERAL ERROR CODES THAT INDICATED SPI BUS FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305266 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1