BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 9458511 · Received December 12, 2019

    Report

    Report Number
    2031642-2019-10826
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Report Date
    December 6, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 23MAR2020 B4: (B)(6)2020. TOUCHSCREEN ASSEMBLY WAS RECEIVED TO FAILURE INVESTIGATION FOR EVALUATION. THE UL_LR AND UR_LL RESISTANCE WERE OUT OF SPECIFICATION. FAULT WERE FOUND ON THIS RETURNED TOUCHSCREEN. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 201920. DATE OF REPORT: 12/12/2019.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TOUCH SCREEN FAILURE. THERE WAS NO PATIENT/USER INVOLVEMENT. THE FSE (FIELD SERVICE ENGINEER) EVALUATED THE DEVICE AND CONFIRMED THE REPORTED ISSUE. THE SERVICE TECHNICIAN REPLACED THE TOUCH SCREEN. THE VENTILATOR WAS CALIBRATED SUCCESSFULLY AND PASSED ALL REQUIRED TESTING. THE REPORTED ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257873 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1