BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 10942343 · Received December 3, 2020

    Report

    Report Number
    2031642-2020-04407
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    November 24, 2020
    Report Date
    November 26, 2020
    Product Code
    MNT
    UDI-DI
    00884838089280
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: (B)(6) 2021. B4: (B)(6) 2021. H11:G5:K102985 H10:THE CPU (PCBA, CPU, V680) WAS RETURNED TO THE FAILURE INVESTIGATION LABORATORY FOR ANALYSIS. VISUAL INSPECTION REVEALED NO ANOMALIES NOTED. TEST VENTILATOR WITH RETURNED CPU ENTERS AND EXITS STANDBY MODE NORMALLY. THE CUSTOMER COMPLAINT WAS NOT VERIFIED. THERE WAS NO FAULT FOUND. 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

    G4:22JAN2021. B4:25JAN2021. THIS WAS A MALFUNCTION OF THE TOUCHSCREEN AND CENTRAL PROCESSING UNIT PCBA. 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 EVENTS: (B)(6) 2020. (B)(6) 2020. 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 RESPIRONICS V60 VENTILATOR¿S TOUCHSCREEN WAS UNRESPONSIVE, WOULD NOT ENTER STANDBY MODE OR ALLOW THE HOSPITAL STAFF TO RESET AN ALARM, AND THE PATIENT REQUIRED ADMISSION TO THE HOSPITAL¿S INTENSIVE CARE UNIT (ICU). THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED DEVICE BEHAVIOR AND MEDICAL INTERVENTION. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE. THE REPORTED ISSUE WAS CONFIRMED AND TRACED TO A FAULTY TOUCH SCREEN AND CPU PCBA. THE FSE REPLACED THE TOUCH SCREEN AND CPU PCBA. 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 WITH SOFTWARE VERSION 2.10; 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 DEVICE, THE DEVICE GENERATED AN ALARM; DETAILS NOT REPORTED, HOSPITAL STAFF THEN ATTEMPTED TO PLACE THE DEVICE IN STANDBY MODE, THE TOUCHPAD WAS UNRESPONSIVE, THE SCREEN DISPLAYED STANDBY MODE, BUT THE DEVICE CONTINUED TO DELIVER THERAPY, THE HOSPITAL STAFF WAS UNABLE TO RESET THE ALARM GENERATED, AND THE PATIENT REQUIRED MEDICAL INTERVENTION; DETAILS NOT PROVIDED, THAT REQUIRED THE PATIENT TO BE ADMITTED TO THE HOSPITAL¿S INTENSIVE CARE UNIT (ICU). NO RELEVANT LABORATORY DATA WAS REPORTED. AS OF (B)(6) 2020, IT IS UNKNOWN IF THE PATIENT CONTINUES TO BE ADMITTED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407670 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60 00884838089280

    Patients

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