BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10813856 · Received November 9, 2020

    Report

    Report Number
    2031642-2020-04140
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Report Date
    October 25, 2020
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:27NOV2020. THE DEVICE WAS EVALUATED BY A PHILIPS INTERNATIONAL FIELD SERVICE ENGINEER (FSE) WHO REPORTED THE PHENOMENON COULD NOT BE CONFIRMED DESPITE OPERATION CHECK. THE FSE REPLACED THE DATA ACQUISITION BOARD MONITORING PRESSURE AND FLOW SENSOR ASSEMBLY MEASURING AIRFLOW RATE WERE REPLACED PREVENTATIVELY. NO OTHER ANOMALIES G4:11FEB2021. THE CUSTOMER RETURNED GDS (GAS DELIVERY SYSTEM) ASSEMBLY AND DATA ACQUISITION (DAQ) BOARD REVEALED NO ANOMALIES VIA VISUAL INSPECTION. A FAILURE INVESTIGATION (FI) TECHNICIAN INSTALLED THE GDS (GAS DELIVERY SYSTEM) ASSEMBLY AND DATA ACQUISITION BOARD (DAQ) INTO A FI VENTILATOR TO DUPLICATE THE REPORTED ISSUE OF PROXIMAL PRESSURE LINE DISCONNECT. THE FI TECHNICIAN CONCLUDED THAT THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED. THE RETURNED GDS AND DAQ BOARD PASSED ALL 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: 09NOV2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT DISCONNECT ALARM DURING CLINICAL USE. THE PHENOMENON WAS SAID TO NOT HAVE REOCCURRED. THE FIELD SERVICE ENGINEER EVALUATION IS PENDING. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED. THERE WAS NO DELAY TO PATIENT THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272031 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

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