BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 11016769 · Received December 16, 2020

    Report

    Report Number
    2031642-2020-04567
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    November 18, 2020
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 18MAR2021. B4: 24MAR2021. THE DATA ACQUISITION ASSEMBLY (DAQ) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALIES. A FAILURE INVESTIGATION (FI) TECHNICIAN INSTALLED THE DAQ INTO A FI VENTILATOR TO DUPLICATE THE REPORTED ISSUE. DURING THE UNIT TESTING THE DAQ WAS INSTALLED IN THE FI TEST VENTILATOR AND BOOTED IN NORMAL OPERATION MODE AND CHECKED FOR ALARMS AND ERRORS. NO FAULT FOUND ON THE RETURNED PART. FI INVESTIGATION COULD NOT REPLICATE PROBLEM AND THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. 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. (B)(6) 2020. 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

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE ALARMED WITH A CODE PROXIMAL PRESSURE SENSOR CALIBRATION DATA ERROR. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THE VENTILATOR WAS SWAPPED AND THERE WAS NO PATIENT OR USER HARM REPORTED. THE CUSTOMER REQUESTED THAT A PHILIPS FIELD SERVICE ENGINEER (FSE) BE DISPATCHED TO THE CUSTOMER SITE. THE FSE CONFIRMED THE REPORTED ISSUE AND DETERMINED THE DATA ACQUISITION PCBA REQUIRED REPLACEMENT. THE FSE REPLACED THE DATA ACQUISITION PCBA TO RESOLVE THE REPORTED PROBLEM. THE DEVICE PASSED ALL TESTING AND RETURNED TO FULL FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484706 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER