BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11704922 · Received April 22, 2021

    Report

    Report Number
    2031642-2021-03458
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 6, 2021
    Product Code
    MNT
    UDI-DI
    00884838009851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:21APR2021. B4:10MAY2021. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER COULD NOT CONFIRM OR DUPLICATE THE REPORTED FAILURE. THE REMOTE SERVICE ENGINEER (RSE) REFERRED THE CUSTOMER TO THE SERVICE GUIDE AND ADVISED THE REPLACEMENT OF THE DATA ACQUISITION BOARD (DAQ) BOARD. THE FIELD SERVICE ENGINEER (FSE) CHECKED FOR PROPER OPERATION ALONG WITH A CHECK OF VARIOUS MODES, EVERYTHING WAS CORRECT. NO PARTS WERE REPLACED. THE UNIT WAS TESTED, AND IT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PROXIMAL PRESSURE SENSOR INTERVAL ERROR. THE REMOTE SERVICE ENGINEER (RSE) REFERRED THE CUSTOMER TO THE SERVICE GUIDE AND ADVISED REPLACEMENT OF DATA ACQUISITION BOARD (DAQ) BOARD. THE UNIT WAS NOT IN USE, AND THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606553 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1