BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 10063686 · Received May 15, 2020

    Report

    Report Number
    2031642-2020-01745
    Event Type
    Malfunction
    Date Received
    May 15, 2020
    Report Date
    April 24, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 15MAY2020 B4: (B)(6)2020 THE CUSTOMER REPORTED TO HAVE TRIED TROUBLESHOOTING WITH MULTIPLE MMI CABLES AND SUSPECTED ONE OF THEM TO HAVE BEEN FAULTY AS THE CABLE WAS REPLACED AGAIN AND THE PROBLEM WAS RESOLVED. 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: 15MAY2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SOME PLACES OF THE TOUCHSCREEN ARE UNRESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT. TECHNICAL SUPPORT PROVIDED REMOTE ASSISTANCE TO THE CUSTOMER. THE CUSTOMER REPORTED TO HAVE ALREADY REPLACED THE TOUCH FRAME, THE MAN-MACHINE INTERFACE (MMI) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), AND THE CABLE BETWEEN THEM IN AN ATTEMPT TO RESOLVE THE PROBLEM. TECHNICAL SUPPORT ADVISED THE CUSTOMER TO REPLACE THE DIGITAL, ANALOG, CENTRAL PROCESSING UNIT (CPU), OR MAIN PCBAS FOR TROUBLESHOOTING. THE CUSTOMER REPORTED THAT REPLACING THESE PARTS DID NOT RESOLVE THE PROBLEM SO THEY WILL CONTINUE TROUBLESHOOTING WITH TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524240 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1