BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 15257549 · Received August 19, 2022

    Report

    Report Number
    2016493-2022-179586
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    July 28, 2022
    Report Date
    July 13, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    CCK
    UDI-DI
    10885403830013
    PMA / PMN Number
    K031741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Additional Manufacturer Narrative · 0

    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 WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Additional Manufacturer Narrative · 0

    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 WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WHEN CONNECTED TO PCU GETS AN ERROR MESSAGE, PLUS COMMUNICATION ERROR AND ERROR CODE 09-100-1318. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WHEN CONNECTED TO PCU GETS AN ERROR MESSAGE, PLUS COMMUNICATION ERROR AND ERROR CODE 09-100-1318. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WHEN CONNECTED TO PCU GETS AN ERROR MESSAGE, PLUS COMMUNICATION ERROR AND ERROR CODE 09-100-1318. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848851 ALARIS SYSTEM ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK CAREFUSION SD 8300 10885403830013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown