BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 11102972 · Received December 31, 2020

    Report

    Report Number
    2031642-2020-04810
    Event Type
    Injury
    Date Received
    December 31, 2020
    Date of Event
    December 20, 2020
    Report Date
    December 22, 2020
    Product Code
    MNT
    UDI-DI
    00884838089280
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:23FEB2021. B4:24FEB2021. H11:G5:K102985. H10: PHILIPS REPAIR BENCH TECHNICIAN EVALUATED THE DEVICE, THE REPORTED ISSUE WAS NOT DUPLICATED, AND NO FAULT WAS FOUND. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE WITH THE CUSTOMER. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED DEVICE SYMPTOM. PHILIPS WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM AS IT 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: 31DEC2020. 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 DELIVERING THERAPY TO A PATIENT, THE V60 VENTILATOR WOULD NOT ENTER STANDBY MODE, AND THE PATIENT EXPERIENCED AN EVENT OF OXYGEN DESATURATION. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED DEVICE BEHAVIOR AND ADVERSE EVENT. 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; PRESCRIPTION, DEVICE SETTINGS, CONFIGURATION, PATIENT CIRCUIT, AND PATIENT INTERFACE NOT REPORTED. WHILE ADMITTED ON (B)(6) 2020, THE PATIENT WAS RECEIVING THERAPY VIA THE V60, THE DEVICE WOULD NOT ENTER STANDBY MODE, AND THE PATIENT EXPERIENCED AN EVENT OF OXYGEN DESATURATION; VALUES NOT REPORTED. NO RELEVANT LABORATORY DATA WAS REPORTED. THE OUTCOME OF THE PATIENT EXPERIENCING AN EVENT OF OXYGEN DESATURATION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567904 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60 00884838089280

    Patients

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