BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8300 ALARIS ETCO2 MODULE

    MDR report key: 10967764 · Received December 8, 2020

    Report

    Report Number
    2016493-2020-60678
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Report Date
    March 5, 2019
    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 FOR THE SUSPECT DEVICE. 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. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). CASE DESCRIPTION: WHEN 8300 IS PLUGIN TO 8015 DEVICE, ONCE POWER UP, ERROR 9-100-1318 WILL SHOW UP. FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT. FAILURE PROBLEM TYPE: 8300. FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: RECOMMENDED TO RE-FLASHED THE 8300 TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434192 8300 ALARIS ETCO2 MODULE PUMP, INFUSION CCK CAREFUSION SD 8300

    Patients

    Seq Age Sex Outcome Treatment
    1