BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16251395 · Received January 26, 2023

    Report

    Report Number
    2016493-2023-102012
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 11, 2023
    Report Date
    January 12, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    UDI-DI
    10885403830013
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8300 HAD ERROR CODE 9-100-1318. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616256 ALARIS SYSTEM ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK CAREFUSION SD 8300 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown