BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V680 VENTILATOR

    MDR report key: 11091306 · Received December 29, 2020

    Report

    Report Number
    2031642-2020-04772
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    December 20, 2020
    Report Date
    December 22, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    UDI-DI
    00884838053595
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: 30DEC2020. B4: 30DEC2020. CORRECTION: THE V680 IS AN EXPORTED DEVICE AND NOT AVAILABLE FOR COMMERCIAL DISTRIBUTION IN THE UNITED STATES, THEREFORE DOES NOT FALL WITHIN FDA REPORTING GUIDELINES. 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

    EVENT DATE: (B)(6) 2020. REPORT DATE: 29DEC2020.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT WHILE DELIVERING THERAPY TO A PATIENT, THE RESPIRONICS V680 VENTILATOR BECAME DISCONNECTED FROM THE PATIENT, DID NOT GENERATE AN ALARM, AND THE PATIENT REQUIRED MANUAL VENTILATION. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED DEVICE BEHAVIOR AND MEDICAL INTERVENTION. 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 V680 VENTILATOR; PRESCRIPTION, DEVICE SETTINGS, CONFIGURATION, PATIENT CIRCUIT, AND PATIENT INTERFACE NOT REPORTED. WHILE ADMITTED ON (B)(6) 2020 AT APPROXIMATELY 1000, THE PATIENT WAS RECEIVING THERAPY VIA THE V680 DEVICE, THE PATIENT BECAME DISCONNECTED FROM THE DEVICE, THE DEVICE DID NOT GENERATE ANY AUDIBLE ALARMS, HOSPITAL STAFF ADMINISTERED MANUAL VENTILATION, AND THE PATIENT WAS THEN RECONNECTED TO THE V680 VENTILATOR. NO RELEVANT LABORATORY DATA WAS REPORTED. POST EVENT, THE HOSPITAL'S BIOMEDICAL ENGINEER REVIEWED THE DEVICE'S DIAGNOSTIC REPORT (DRPT), AND REPORTED THAT THE DEVICE GENERATED SEVERAL PATIENT DISCONNECT ALARMS DURING THE EVENT. NO ADVERSE EVENT WAS REPORTED OR ASSOCIATED WITH THE USE OF THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556910 V680 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE PRODUCT CODE: CBK CBK RESPIRONICS CALIFORNIA, INC V680 00884838053595

    Patients

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