BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 8650110 · Received May 29, 2019

    Report

    Report Number
    2031642-2019-03289
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Report Date
    May 9, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT : 19JUL2019, DATE REC¿D BY MFR : 03JUL2019. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN CONFIRMED THE REPORTED ISSUE. ADDITIONAL ERRORS WERE NOTED. 9003- FLOW SENSOR FAILURE. 9004- PRESSURE SENSOR FAILURE. A/D CONVERTER OUT OF RANGE. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE DEFECTIVE 3-STATION SOLENOID, MAIN BOARD W/LITHIUM BATTERY, AND THE PCBA, MMI, COLOR DISPLAY TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. 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

    DATE RECEIVED BY MFR: (B)(6) 2019. DATE OF REPORT: (B)(6) 2019. THE PCBA, MMI, ESPRIT/V200 COLOR DISPLAY, CABLE, CABLE,MMI BOARD TO OVERLAY_1, MMI BOARD TO OVERLAY_2, AND PCBA,MAIN BOARD WITH LITHIUM BATTERY WAS RETURNED TO FAILURE INVESTIGATION (FI) FOR EVALUATION. NO SIGNS OF DAMAGE OR CONTAMINATION FOUND. THE CABLE,MMI BOARD TO OVERLAY_1 HOWEVER, DID REVEAL SIGNS OF DRIED CONTAMINATION. THE CUSTOMER RETURNED MMI BOARD, MAIN BOARD, AND BOTH CABLES WILL BE INSTALLED INTO THE FI TEST VENTILATOR. THE VENTILATOR REMAINED OPERATIONAL WITH NO ERRORS DETECTED. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE 3 STATION SOLENOID, MAIN BOARD W/LITHIUM BATTERY,PCBA, MMI, ESPRIT/V200 COLOR DISPLAY, AND BOTH MMI TO OVERLAY CABLES LABELED #1 AND #2 AND TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS NOT BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS NOT A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM. THIS CUSTOMER RETURNED MMI BOARD WAS TESTED WITH NO FAILURES IDENTIFIED. THIS CUSTOMER RETURNED MAIN BOARD WAS TESTED WITH NO FAILURES IDENTIFIED. BOTH MMI TO OVERLAY CABLES LABELED #1 AND #2 WERE TESTED WITH NO FUNCTIONAL FAILURES IDENTIFIED. 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) 2019. DATE OF REPORT: 29MAY2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERROR FAILED KEY PAD TEST. THE DEVICE WAS NOT IN USE AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443654 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1