BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 8621465 · Received May 17, 2019

    Report

    Report Number
    2031642-2019-03050
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    May 1, 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

    MFR RECEIVED DATE: 24 SEP 2019. THE CUSTOMER RETURNED SWITCH CIRCUIT PANEL ASSEMBLY WAS TESTED WITH NO 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 · 0

    DATE RECEIVED BY MANUFACTURER: 29MAY2019. DATE OF REPORT: 11JUN2019. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN CONFIRMED THE REPORTED ISSUE. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE KEYPAD OVERLAY TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. NO PARTS WERE RETURNED TO FAILURE INVESTIGATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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: 17MAY2019. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS UNABLE TO GO INTO DIAGNOSTIC MODE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415318 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1