BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8300 ALARIS ETCO2 MODULE

    MDR report key: 11144826 · Received January 10, 2021

    Report

    Report Number
    2016493-2021-03859
    Event Type
    Malfunction
    Date Received
    January 10, 2021
    Report Date
    February 6, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    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

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, RETESTED AND RETURNED TO THE CUSTOMER. 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 RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    LOGIC BOARD- SOFTWARE FAULT REFLASH ORIDION BOARD- FAILED CO2 CAL TEST CASE FRONT- DAMAGED/CRACKED IUI- ISOLATION RIB DAMAGE SOFT FAULT- OTHER- SPECIFY IN COMMENTS 9-100-1426 , FAILED PM- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40725 8300 ALARIS ETCO2 MODULE PUMP, INFUSION CCK CAREFUSION SD 8300 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1