BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 18317980 · Received December 13, 2023

    Report

    Report Number
    2016493-2023-249532
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 28, 2023
    Report Date
    December 13, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    UDI-DI
    10885403830020
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SECTION H6 OF 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. H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** CORRECTION: MEDICAL DEVICE TYPE, UNIQUE DEVICE IDENTIFIER (UDI)#, PMA / 510(K)# ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD.

    Additional Manufacturer Narrative · 0

    CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI)#

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ETCO2 UNIT HAD ERROR CODE 570.6200. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ETCO2 UNIT HAD ERROR CODE 570.6200. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ETCO2 UNIT HAD ERROR CODE 570.6200. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581281 ALARIS SYSTEM ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK CAREFUSION SD 8300 10885403830020
    2333893 ALARIS SYSTEM ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK CAREFUSION SD 8300 10885403830020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8100