BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8300 ALARIS ETCO2 MODULE

    MDR report key: 10902986 · Received November 25, 2020

    Report

    Report Number
    2016493-2020-48078
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    September 13, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403830013
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). CUSTOMER CALLED IN FOR HELP ON ETCO2 UNIT HAS ERROR CODE 9-100-1426 WHICH IS THE SOFTWARE ON UNIT IS CORRUPT NEEDS TO REFLASH SOFTWARE EXPLAIN TO CUSTOMER HOW THE FLASH WORKS, ALSO WALK CUSTOMER THROUGH HIS ASM SOFTWARE TO LOCATE IN HIS PROFILE WEATHER HIS FIRM WARE FILES WERE LOADED THEY WERE NOT CUSTOMER GOING TO TRY AND LOCATE THE CD GUARDAIL POC IF HE CAN'T LOCATE SOFTWARE CUSTOMER WILL CALLL BACK SO WE CAN SEND HIM OUT A REPLACEMENT SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368704 8300 ALARIS ETCO2 MODULE PUMP, INFUSION FRN CAREFUSION SD 8300 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1