BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6278760 · Received January 26, 2017

    Report

    Report Number
    2031642-2017-00316
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Report Date
    December 20, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE INVESTIGATION (FI) LAB RECEIVED DATA ACQUISITION (DA) PCB ASSEMBLY FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DA PCB ASSEMBLY REVEALED NO SIGNS OF DAMAGE OR CONTAMINATION WERE FOUND. THE DA BOARD WAS TESTED IN DIAGNOSTIC MODE THE DIGITAL TO ANALOG CONVERTERS (DACS) TO ANALOG TO DIGITAL CONVERTERS (ADCS) WRAP SHOWED ONLY A SMALL DIFFERENCE (MAXIMUM 5 COUNTS). THE VENTILATOR WAS RUN IN NORMAL VENTILATION FOR 2 HOURS WITHOUT ANY ERRORS OCCURRING. NO FAILURES WERE IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED DUE TO NO PROBLEM FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT HAS ERROR CODE MESSAGE OF DATA ACQUISITION/PRINTED CIRCUIT BOARD ASSEMBLY/ ANALOG DIGITAL CONVERTER (DA) PCBA ADC FAILED. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61675 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1