BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10063233 · Received May 15, 2020

    Report

    Report Number
    2031642-2020-01728
    Event Type
    Malfunction
    Date Received
    May 15, 2020
    Report Date
    April 23, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 06AUG2020. B4: 06AUG2020. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE VERIFIED THE FAILURE AT BOOT UP. THE FSE REPLACED THE SOLENOID VALVE 3 AND 4 AND THE DATA ACQUISITION (DAC) BOARD TO RESOLVE 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.

    Additional Manufacturer Narrative · 0

    G4: 06OCT2020; B4: 08OCT2020. THE DATA ACQUISITION ASSEMBLY (DAQ (ASSY,PCB,DATA ACQ, V8000) WAS RETURNED FOR FAILURE ANALYSIS. VISUAL INSPECTION REVEALED THE REVEALED NO ANOMALIES. A FAILURE INVESTIGATION (FI) TECHNICIAN DAQ ONTO KNOWN GOOD TEST UNIT. BOOT UNIT IN NORMAL OPERATION MODE AND CHECK FOR ALARMS AND ERRORS. IF NO ERRORS FOUND, PROCEED TO TEST #2. THE DAQ SYSTEM WAS INSTALLED INTO THE FI TEST VENTILATOR. AN ATTEMPT TO BOOT INTO THE NORMAL VENTILATION MODE WAS MADE. DURING THE UNIT TESTING THE REPORTED ISSUE WAS NOT DUPLICATED. THE FI INVESTIGATION COULD NOT REPLICATE THE REPORTED PROBLEM AND THE REPORTED PROBLEM COULD NOT BE REPRODUCED. 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: 15MAY2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MACHINE AND PROXIMAL PRESSURE SENSOR FAILURE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525097 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1