BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8300 ALARIS ETCO2 MODULE

    MDR report key: 10792318 · Received November 5, 2020

    Report

    Report Number
    2016493-2020-32177
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    March 12, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    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 NOT PERFORMED BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED. CAPA REFERENCE: (B)(4) THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). CUSTOMER (B)(6) CALLED IN FOR HELP ON ETCO2 UNIT HAS ERROR CODE 511-2010 WHICH IS A WATCHDOG ERROR ON UNIT COMMUNICATION ERROR UNIT IS UNRESTORABLE WILL HAVE TO COME IN FOR SERVICES REPAIR. CUSTOMER WILL CALL BACK ONCE SHE HAS THE PO # TO SET UP UNIT FOR SERVICES REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260857 8300 ALARIS ETCO2 MODULE PUMP, INFUSION CCK CAREFUSION SD 8300

    Patients

    Seq Age Sex Outcome Treatment
    1