BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCI CAPNOCHECK SLEEP OXIMETER

    MDR report key: 9132077 · Received September 27, 2019

    Report

    Report Number
    3012307300-2019-05194
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Report Date
    September 27, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CCK
    UDI-DI
    10610586036866
    PMA / PMN Number
    K970209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION : ONE BCI MONITOR AND ADAPTER WAS RECEIVED FOR INVESTIGATION IN GOOD CONDITION. AFTER CHARGING THE 9004050 MONITOR OVERNIGHT, PRESSING THE ON/OFF BUTTON TO POWER UP THE MONITOR, IT WAS DETERMINED THE DEVICE WOULD NOT TURN ON. NEXT, THE INVESTIGATOR PLUGGED IN THE AC/DC 1616 ADAPTER FOR A FACTORY CALIBRATION. WITHOUT USING THE POWER FROM THE MAIN BATTERY, AND ONLY TAKING POWER FROM THE AC/DC 1616 POWER SUPPLY, THE MONITOR WOULD NOT POWER ON. THEREFORE, THE MAIN BOARD WAS REPLACED. THE MAIN BOARD FAILURE CONFIRMS THE CUSTOMER'S REPORTED COMPLAINT. IN ADDITION, THE DEVICE CO2 AND FLOW RATE WAS TESTED WITH FLOW OF 166 ML/MIN (SPEC: 150+/-20ML/MIN) AND PASSED. FURTHERMORE, IT WAS DETECTED THAT THE TAMPER STICKER WAS NOT INTACT, IMPLYING CUSTOMER MAY HAVE INDUCED DAMAGE. THE CHARGING CIRCUIT ON THE MAINBOARD FAILING TO CHARGE BATTERY WAS NOTED TO BE KNOWN FOR RESULTING FROM THE USE OF WRONG POWER SUPPLY, CAUSING THE MAINBOARD TO SHORT. BASED ON THE EVIDENCE, THE COMPLAINT ALLEGATION WAS CONFIRMED. THE FAILURE LIKELY RESULTED FROM A USER ERROR FAILING TO FOLLOW THE CORRECTION INSTRUCTIONS FROM THE OPERATOR'S MANUAL (CHAPTER ONE) WHERE IT STATES ""PATIENT SAFETY CAN BE COMPROMISED BY THE USE OF A POWER SUPPLY NOT SUPPLIED BY SMITHS MEDICAL. USE ONLY THE POWER SUPPLY INCLUDED WITH YOUR MONITOR, OR APPROVED BY SMITHS MEDICAL."

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BCI CAPNOCHECK SLEEP OXIMETER HAD A CHARGING CIRCUIT ISSUE. THE REPORTER ALSO STATED THE DEVICE "REQUIRED FACTORY CALIBRATION". NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924380 BCI CAPNOCHECK SLEEP OXIMETER ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK SMITHS MEDICAL ASD, INC. 9004050 10610586036866

    Patients

    Seq Age Sex Outcome Treatment
    1