BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6978666 · Received October 25, 2017

    Report

    Report Number
    2031642-2017-03420
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Report Date
    October 4, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Removal / Correction Number
    Z-2061-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED POWER MANAGEMENT (PM) BOARD, MOTOR CONTROLLER (MC) BOARD AND DATA ACQUISITION (DA) BOARD TO ADDRESS THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS ON THE RETURNED POWER MANAGEMENT (PM) BOARD, DATA ACQUISITION (DA) BOARD AND MOTOR CONTROLLER (MC) BOARD SHOWS THAT THE U28 PIN 6 INTERNAL SHORTED TO PIN 8 (GND) ON THE MOTOR CONTROLLER PCBA AND THE U16 PIN 6 INTERNAL SHORTED TO PIN 8 (GND) ON THE POWER MANAGEMENT PCBA CREATED THE 1007 ERROR CODE VENT INOP.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER (FSE) STATES THAT THE SERVICE SCREENS SHOWS XXXXXX AND NO OTHER INFO FOR EVERY BOARD EXCEPT THE CPU BOARD. T SHUT DOWN..THE F.S.E. REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755284 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1