BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPNOFLEX LF

    MDR report key: 6916126 · Received October 5, 2017

    Report

    Report Number
    6916126
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    June 22, 2017
    Report Date
    September 21, 2017
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    STAFF TRIED TO USE THE CAPNOFLEX MODULE ON A DASH 4000 TO GET A CO2 READING. THE DAILY OPERATIONAL CHECK WAS PERFORMED AS DESCRIBED IN THE OPERATOR MANUAL AND THE UNIT DID ZERO AS IT WAS SUPPOSED TO, BUT ONCE IT WAS PLACED ON A PATIENT IT WOULD NOT READ ANY RESPIRATION. STAFF TRIED ANOTHER DEVICE AND THE SAME THING HAPPENED; FINALLY, THEY TRIED A 3RD MODULE AND IT WORKED. THE STAFF HAD LOST CONFIDENCE IN ALL OF THEIR MODULES AND ASKED BIOMED TO CHECK THEM ALL. THE ER ONLY HAS 8 OF THESE AND 3 OF THE 8 WERE FOUND TO HAVE THE SAME PROBLEM. OPENED THE UNIT AND FOUND THE INTERNAL HOSE DISCONNECTED. MANUFACTURER RESPONSE: FOR CO2 MODULE, GE (PER SITE REPORTER). THEY OFFERED TO REPAIR IT AT A FLAT RATE OF (B)(6) AND NO FURTHER SUPPORT WAS GIVEN. MANUFACTURER RESPONSE: FOR CO2 MODULE, GE (PER SITE REPORTER). OFFERED TO REPAIR IT AND A FLAT RATE OF (B)(6). NO FURTHER SUPPORT WAS GIVEN. MANUFACTURER RESPONSE: FOR CO2 MODULE, GE (PER SITE REPORTER). SEND IT IN FOR REPAIR AT A FLAT RATE OF (B)(6). NO OTHER SUPPORT WAS GIVEN. I HAD 3 OF THESE AND SINCE IT WAS BROKEN I DECIDED TO OPEN IT UP TO FIND THAT IT WAS A VERY SIMPLE FIX

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698019 CAPNOFLEX LF ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE CCK GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 2013427-001

    Patients

    Seq Age Sex Outcome Treatment
    1