BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8300 ALARIS ETCO2 MODULE

    MDR report key: 10710086 · Received October 21, 2020

    Report

    Report Number
    2016493-2020-24858
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Report Date
    March 13, 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 PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICE. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE 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. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE ID: (B)(4). CASE STATUS: OPEN. SUMMARY: SENSOR CALIBRATION TEST. CASE NOTES: (B)(4). NPI. ETCO2 UNIT. CUSTOMER (B)(6) CALLED IN FOR HELP ON ETCO2 UNIT. HE IS TRY TO RUN SENSOR CALIBRATION WITH THE GAS CONNECT AND FLOW METER, BUT UNIT IS FAILING ON SAME SETUP THREE UNITS SO FAR FAILING. THEY RECEIVE CASE OF THE GAS THINKS HE HAS SOME BAD CANS HE WILL CALL THE COMPANY HE ORDER THE GAS FROM AIR LIQUID AND GET THOSE REPLACE CALL US BACK IF HE NEEDS TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178484 8300 ALARIS ETCO2 MODULE PUMP, INFUSION CCK CAREFUSION SD 8300

    Patients

    Seq Age Sex Outcome Treatment
    1