BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 7065897 · Received November 28, 2017

    Report

    Report Number
    2031642-2017-03645
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Report Date
    November 3, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS ON THE RETURNED MOTOR CONTROLLER (MC) BOARD SHOWS THAT THE SPI DRIVER U28 ON THE (MC) BOARD HAD A SHORTED LINE WHICH CAUSED THE SPI BUS TO MALFUNCTION AND ALARM E/C1007 (MACHINE AND PROXIMAL PRESSURE SENSORS FAILED) TO BE TRIGGERED. REPLACING U28 RESOLVED THE PROBLEM AND THE VENTILATOR STARTED UP AND DELIVERED BREATHS WITHOUT ANY ERRORS OCCURRING.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) REPORTED THAT AFTER REPLACING THE DATA ACQUISITION (DA) PCBA TO MOTOR CONTROLLER (MC) PCBA CABLE, THE UNIT WAS GIVEN AN ERROR CODE MESSAGE OF MACHINE AND PROXIMAL PRESSURE SENSORS FAILED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842157 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1