BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11772969 · Received May 4, 2021

    Report

    Report Number
    2031642-2021-03586
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 5, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B4:(B)(6) 2021 THE CUSTOMER REPLACED THE DATA ACQUISITION BOARD TO CORRECT THE ISSUE. THE UNIT WAS TESTED, AND IT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT CAME DOWN FROM THE FLOOR WITH REPORTED ERROR CODES. THE CUSTOMER CONFIRMED DIAGNOSTIC ERROR CODES "BAROMETER CALIBRATION DATA ERROR", "OXYGEN (O2) FLOW SENSOR CALIBRATION DATA ERROR", "AIR FLOW SENSOR CALIBRATION DATA ERROR", "OXYGEN (O2) PRESSURE SENSOR CALIBRATION DATA ERROR", "MACHINE AND PROXIMAL PRESSURE SENSORS FAILED", "PROXIMAL PRESSURE SENSOR CALIBRATION DATA ERROR", AND "MACHINE PRESSURE SENSOR CALIBRATION DATA ERROR". THE CUSTOMER NOTED THAT THE AIR FLOW SENSOR, (DAQ) BOARD, AND THE (O2) FLOW SENSOR ARE NOT DISPLAYING A SERIAL NUMBER. THE REMOTE SERVICE ENGINEER (RSE) ADVISED REPLACEMENT OF THE DATA ACQUISITION (DAQ) BOARD AND THE DATA ACQUISITION (DA) TO MOTOR CONTROLLER (MC) CABLE. THE UNIT WAS IN CLINICAL USE; THERE WAS NO PATIENT HARM WHEN PATIENT WAS CHANGED OUT TO ANOTHER VENTILATOR. IN CLINICAL USE; THERE WAS NO PATIENT HARM WHEN PATIENT WAS CHANGED OUT TO ANOTHER VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666497 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1