BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 10652232 · Received October 8, 2020

    Report

    Report Number
    2031642-2020-03640
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Report Date
    September 18, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 27SEP2020 B4: (B)(6) 2020 THE FIELD SERVICE ENGINEER (FSE) COULD NOT VERIFY THE CUSTOMER REPORTED PROBLEM OF AIR FLOW IS NOT COMING, BUT THE (FSE) FOUND THAT AUDIBLE ALARM FAILED MESSAGE IS SHOWING. ALARM PIEZO OBO-35TA , RP-CABLE FLEX CIRCUIT ARE FOUND DEFECTIVE. THE (FSE COULD NOT COMPLETE THE REPAIR ON THIS UNIT, BECAUSE THE UNIT IN THE COVID WARD. 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: 16JAN2021. B4: 19JAN2021. PER FIELD SERVICE ENGINEER (FSE), THE CUSTOMER REPORTED THAT AIRFLOW WAS NOT COMING, BUT THE FSE FOUND THAT THE VENTILATOR WAS GIVING AN AUDIBLE ALARM FAILURE. THE FSE FOUND THE ALARM LED AND BATTERY LED IS NOT WORKING. SO ALARM PIEZO OBO-35TA & RP-CABLE FLEX CIRCUIT HAVE BEEN REPLACED. THE REPAIR HAS BEEN COMPLETED, AND NOW THE VENTILATOR IS BACK FOR PATIENT USE. 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: 08OCT2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AIR FLOW IS NOT COMING. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND REQUESTED FOR SERVICE REPAIR. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT, BUT THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118260 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

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