BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 9087141 · Received September 19, 2019

    Report

    Report Number
    2031642-2019-09716
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Report Date
    September 11, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 17JAN2020. B4: (B)(6). THE FSE REVISITED THE SITE AND REPLACED THE MMI AND GUI AT THE SAME TIME. THE TOUCHSCREEN WAS STILL UNRESPONSIVE. THE FSE THEN REPLACED THE MMI TO TOUCHSCREEN CABLES AND THE ISSUE WAS RESOLVED. THE TOUCHSCREEN WAS FULLY OPERATIONAL. THE UNIT PASSED EXTENDED SELF TESTING (EST) AND WAS RETURNED TO SERVICE. 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: 26FEB2020. B4: 26FEB2020. THE MOTOR CONTROLLER BOARD, SENSOR BOARD, MMI BOARD AND CABLES WERE RETURNED FOR FAILURE ANALYSIS. A VISUAL INSPECTION REVEALED NO SIGNS OF DAMAGE OR CONTAMINATION. DURING TESTING, IT WAS DETERMINED THAT THE MMI BOARD SHORTED AT C22. REPLACEMENT OF THE C22 COMPONENT CORRECTED THE FAILURE. 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: 15DEC2019. REPORT DATE: 19DEC2019. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING AND CONFIRMED THE REPORTED ISSUE. THE UNIT WOULD NOT POWER ON WITH THE BATTERY. THE FSE PLUGGED THE UNIT IN AND THE UNIT EMITTED A BURNING SMELL FROM THE BLOWER MOTOR. THE FSE REPLACED THE BLOWER AND POWERED THE UNIT BACK ON AND THERE WAS NO SMELL. THE FSE ALSO FOUND THAT THE UNIT'S TOUCHSCREEN WAS PARTIALLY UNRESPONSIVE. THE FSE REPLACED THE GRAPHIC USER INTERFACE (GUI), VIDEO GRAPHICS ARRAY (VGA) AND ANALOG PRINTED CIRCUIT BOARD ASSEMBLY( PCBA) FOR THE TOUCHSCREEN ISSUE; HOWEVER, THE SCREEN REMAINED UNRESPONSIVE. THE FSE THEN FOUND THAT THE MAN-MACHINE INTERFACE (MMI) PRINTED CIRCUIT BOARD (PCB) HAD BURN MARKS ON IT. THE MMI PCB WAS REPLACED, THE CONNECTIONS RESEATED, AND GUI BUTTON OPERATIONS VERIFIED THE UNIT POWERED ON BUT THE TOUCHSCREEN WAS NOT OPERATIONAL. THE FSE ORDERED REPLACEMENT GUI AND MMI PCB AND WILL REVISIT THE CUSTOMER SITE TO COMPLETE REPAIRS. 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: 31MAR2020. B4: 01APR2020. A SECOND MMI BOARD WAS RECEIVED FOR FAILURE ANALYSIS. DURING TESTING, NO FAILURES WERE 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: 19SEP2019.

    Description of Event or Problem · 1

    POST TIMER/24V FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889703 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1