BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6144516 · Received December 5, 2016

    Report

    Report Number
    2031642-2016-03316
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    November 7, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DA PCBA ADC FAILED VENT INOP OCCURRENCE (DATA AQUISITION/ PRINTED CIRCUIT BOARD ASSEMBLY/ ANALOG DIGITAL CONVERTER). NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794973 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1