BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 10925816 · Received December 1, 2020

    Report

    Report Number
    2031642-2020-04348
    Event Type
    Injury
    Date Received
    December 1, 2020
    Report Date
    November 5, 2020
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 21JAN2021. B4: 21JAN2021. THE DEVICE WAS EVALUATED BY THE FACILITIES BIOMED WHO CONFIRMED THE REPORTED ISSUE VIA OPERATIONAL CHECK AND THE EVENT LOG. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS A DELAY TO PATIENT THERAPY CAUSED BY THE EVENT. FURTHER DELAY TO PATIENT THERAPY WAS PREVENTED BY SWITCHING THE PATIENT OVER TO A ANOTHER WORKING BIPAP. THE PATIENT DESATURATED DURING THE TIME THAT THE VENTILATOR STOPPED FUNCTIONING AND THE TRANSFER TO THE OTHER BIPAP. THE PATIENT'S SATURATION WAS ABLE TO RECOVER AFTER THE DEVICE SWAP. FURTHER INFORMATION RECEIVED FROM THE REPORTER CONFIRMED DURING THE EVENT OF UNANTICIPATED DEVICE INOPERABILITY AND THERAPY CESSATION, THE PATIENT NOTIFIED CLINICAL STAFF OF DIFFICULTIES BREATHING WHILE ON THE DEVICE. THE PATIENT EXPERIENCED A SEVERE DECREASE IN THEIR MONITORED SATURATION OF PERIPHERAL OXYGENATION (SPO2) FROM 90% WHILE RECEIVING 85% FIO2 TO APPROXIMATELY 50%. A NON-REBREATHER MASK WAS APPLIED TO THE PATIENT WITH 15 L/MIN O2 DURING THIS PERIOD AND THE PATIENT SPO2 RETURNED TO 93% WHILE A BACKUP VENTILATION DEVICE WAS OBTAINED AND POSITIVE PRESSURE THERAPY REINITIATED. NO FURTHER HARM OR INJURY WAS NOTED AS A RESULT OF THIS EVENT. THE CUSTOMER REPLACED THE DATA ACQUISITION PRINTED CIRCUIT BOARD (PCB). THE UNIT WAS REPORTED TO HAVE BEEN REPAIRED. 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: 13FEB2021. B4: 19FEB2021. H11: G5:K102985. H10: THE ALLEGED DATA ACQUISITION PRINTED CIRCUIT BOARD WAS RETURNED AND RECEIVED BY PHILIPS FOR FAILURE INVESTIGATION. THE PART WAS INSPECTED AND TESTED AS PER PHILIPS OUTLINED INVESTIGATIONS PROCEDURES AND YIELDED NO FAULT OR MALFUNCTION WITH INABILITY BY THE INVESTIGATIONS TEAM TO REPLICATE THE REPORTED PROBLEM. 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: 30NOV2020. .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A V60 VENTILATOR THAT SHUTDOWN IN CLINICAL USE ON A PATIENT. THE DEVICE WAS 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
    1390826 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER