BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 11276702 · Received February 3, 2021

    Report

    Report Number
    2031642-2021-00426
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 6, 2021
    Report Date
    January 21, 2021
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: (B)(6) 2021. B4: (B)(6) 2021. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE. NO DEVICE SYMPTOM WAS REPORTED DURING THE ADVERSE EVENT, AND NO DEVICE SYMPTOM WAS REPORTED DURING THE DEVICE EVALUATION. 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: 24FEB2021. B4: 24FEB2021. H11: G5:K102985. H10: PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE SYMPTOM. REVIEW OF THE PROVIDED DIAGNOSTIC REPORT (DRPT) SHOWED NO ERROR CODES WERE GENERATED. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTING AND WAS PLACED BACK INTO USE WITH THE CUSTOMER. THIS REPORTER STATED THAT A PATIENT OF UNKNOWN AGE, GENDER, HEIGHT, AND WEIGHT WAS ADMITTED TO A HOSPITAL ON AN UNKNOWN DATE WITH THE ADMITTING DIAGNOSIS NOT REPORTED. NO RELEVANT MEDICAL HISTORY, RELEVANT PAST DRUG HISTORY OR RELEVANT CONCOMITANT MEDICAL PRODUCTS WERE REPORTED. WHILE ADMITTED ON AN UNKNOWN DATE, THE PATIENT WAS PRESCRIBED VENTILATION THERAPY VIA THE RESPIRONICS V60 VENTILATOR; SOFTWARE VERSION 2.30, PRESCRIPTION, DEVICE SETTINGS, CONFIGURATION, PATIENT CIRCUIT, AND PATIENT INTERFACE NOT REPORTED. WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS RECEIVING THERAPY VIA THE V60 DEVICE AND THE PATIENT ¿FLAT LINED¿. NO RELEVANT LABORATORY DATA WAS REPORTED. NO MEDICAL INTERVENTION WAS REPORTED AND THE OUTCOME OF THE PATIENT EXPERIENCING A FLAT LINE IS UNKNOWN. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. PHILIPS CONTACTED WITH THE HOSPITAL MANY TIMES, BUT THE HOSPITAL DID NOT PROVIDE ANY DETAILS ABOUT THE INJURY EVENT. NO CONCLUSION CAN BE DRAWN AS THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION. 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) 2021. (B)(6) 2021 . 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

    A CUSTOMER REPORTED TO PHILIPS THAT WHILE RECEIVING THERAPY FROM THE RESPIRONICS V60 VENTILATOR, THE PATIENT EXPERIENCED A FLAT LINE. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171358 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

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