BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT MONITORING BCI CAPNOGRAPHY MONITOR ACCESSO

    MDR report key: 12577743 · Received October 5, 2021

    Report

    Report Number
    3012307300-2021-09761
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 2, 2021
    Report Date
    December 3, 2021
    Manufacturer
    NULL
    Product Code
    QLJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD BE DUPLICATED. DHR REVIEW WAS DONE, AND OUT OF THIS JOB OF 30, THERE WAS ONE (1) RECORDED REWORKED SN# DIFFERENT FROM THE REPORTED SN# FOR SIMILAR ERROR. THE JOB FOLDER# (B)(4) OF THE AGENT BENCH SN# (B)(4) ASSEMBLED WITH THIS 1410AG BOARD ALSO SHOWS THE AGENT BENCH PASSED ALL FUNCTIONAL TEST DURING THE JOB WITH MEASURED FREQUENCIES WITHIN RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GAS CALIBRATION FAILED DUE TO AGENT ZERO UNSTABLE ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477326 PATIENT MONITORING BCI CAPNOGRAPHY MONITOR ACCESSO PAITIENT MONITOR QLJ 1410AG 4103219

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown