BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCI

    MDR report key: 12764043 · Received November 7, 2021

    Report

    Report Number
    3012307300-2021-10829
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Report Date
    May 7, 2023
    Manufacturer
    ST PAUL
    Product Code
    CCK
    UDI-DI
    10610586036866
    PMA / PMN Number
    K970209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). PLEASE DISREGARD THE INITIAL REPORT SUBMITTED WITH THE MFR NUMBER: 3012307300-2021-10829. THE REPORT WAS SUBMITTED IN ERROR., CORRECTED DATA: CORRECTED INFORMATION PROVIDED IN H10.

    Additional Manufacturer Narrative · 0

    H10: INVESTIGATION FINDINGS: THE REPORTED COMPLAINT WAS VERIFIED AFTER TEST THE FLOW RATE ON THE RETURNED 9004050 MONITOR AND THERE WAS NO FLOW RATE. WHEN THE MONITOR HAS NO FLOW RATE THE MONITOR WOULD NOT BE ABLE TO CALIBRATE THE C02 DUE TO A LEAK. INTERNAL INSPECT THE INSIDE OF THE DEVICE, THE C02 PUMP WAS FOUND WITH A DISCONNECTED TUBE. THE DISCONNECTED TUBE WAS RE-CONNECTED AND THE FLOW RATE INCREASE. DUE TO THE DISCONNECT TUBE AT THE C02 PUMP, THE TUBING KIT WILL NEED TO BE REPLACE AS A PREVENTIVE MAINTENANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMITHS MEDICAL CAPNOGRAPH CALIBRATED BEFORE RETURNING TO FLOOR AND HE IS NOT GETTING ANY READINGS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656632 BCI ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK ST PAUL 9004050 10610586036866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown