BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8841937 · Received July 30, 2019

    Report

    Report Number
    2031642-2019-05221
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Report Date
    July 17, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DAE OF EVENT: (B)(6) 2019. DATE OF REPORT: 30JUL19. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING AND CONFIRMED THE REPORTED ISSUE. THE FSE USED THE MANUAL TO PERFORM TOUCH SCREEN CALIBRATION TO ADDRESS THE REPORTED ISSUE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TOUCH SCREEN ACCURACY PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634219 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1