BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS ETCO2 MODULE

    MDR report key: 10638028 · Received October 6, 2020

    Report

    Report Number
    2016493-2020-18399
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Report Date
    September 15, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    UDI-DI
    10885403830013
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS/UPDATES WERE MADE TO: G4, G7, H2, H3, H6 (METHOD, RESULTS, CONCLUSION), H10 AND H11. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRED TESTING AND SPECIFICATIONS, AND RELEASED BACK TO THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM DATE OF MANUFACTURE 12/08/2005 TO PRESENT DATE 10/19/2020, AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE TWICE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIRS. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 570.6200. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 570.6200. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100504 ALARIS ETCO2 MODULE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS CCK CAREFUSION SD 8300 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1