BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 9639279 · Received January 28, 2020

    Report

    Report Number
    2031642-2020-00317
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Report Date
    January 10, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 13MAR2020 B4: (B)(6)2020. THE FRONT BEZEL ASSEMBLY WAS RETURNED TO FAILURE INVESTIGATION (FI) FOR EVALUATION. VISUAL INSPECTION OF THE NAVIGATION RING INTERNAL STRUCTURE REVEALED THAT CONTAMINATION WAS FOUND THAT CAUSES THE NAVIGATION RING TO FAIL. THE CUSTOMER COMPLAINT WAS DUPLICATED. FAULT IS FOUND ON TESTING. 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) 2020. DATE OF REPORT: 01/28/2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FAULTY NAV-RING CAUSING THE TOUCH SCREEN TO SHAKE CAUSING NAV RING FAILURE. THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) REMOTELY CONFIRMED THE REPORTED PROBLEM OF NAV-RING CAUSING THE TOUCH SCREEN TO SHAKE. THE FSE CONFIRMED THE CUSTOMER HAD CALIBRATED THE TOUCHSCREEN SUCCESSFULLY AND THAT THE TOUCHSCREEN PASSED DIAGNOSTIC TESTS. THE FSE INSTRUCTED THE CUSTOMER TO ENTER THE PNEUMATICS SCREEN AND DIAL IN SOME PRESSURE VALUES. THE CUSTOMER THEN REPORTED THE NAV-RING WAS SKIPPING. THE FSE REMOTELY PAGED AN ON SITE FSE TO RESOLVE THE NAV RING FAILURE. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) REPLACED THE NAV RING, AND ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103465 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1