BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT

    MDR report key: 7161623 · Received January 3, 2018

    Report

    Report Number
    8030673-2018-00400
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    November 21, 2017
    Report Date
    April 18, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    OGL
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VYAIRE HAS REACHED OUT TO CUSTOMER TO PROVIDE THE COMPLAINT DEVICE FOR FURTHER INVESTIGATION. A UPS LABEL HAS BEEN PROVIDED TO THE CUSTOMER. UNFORTUNATELY, VYAIRE HAS NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION OR THE REQUESTED ADDITIONAL INFORMATION AT THIS TIME. IF A SAMPLE OR ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP EMDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, A PHOTO OF THE DEVICE WAS PROVIDED. IN THE PHOTO THE TEMPERATURE PROBE WAS HANGING LOOSE. THIS COULD CAUSE THE PROBE TO GET STUCK AND PULLED WHILE IT IS BEING MOVED DURING USE. THIS COULD CAUSE THE DISCONNECTION REPORTED BY THE CUSTOMER. IT WAS ALSO OBSERVED IN THE PHOTO THAT THE THREE HOSE CLIPS ARE NOT IN PROPER PLACEMENT ALONG THE PURPLE TUBE. THE CLIPS SHOULD BE PLACED AT APPROXIMATELY EVERY ONE QUARTER OF THE TUBE AS STATED IN THE DRAWING AND MANUFACTURING PROCEDURE. BASED ON THE INVESTIGATION IT IS POSSIBLE THAT THE REPORTED DISCONNECTION WAS RELATED TO INCORRECT POSITIONING OF THE HOSE CLIPS. THE MANUFACTURING PROCEDURE FIVES THE RESPONSIBILITY TO THE OPERATOR TO PLACE THE HOSE CLIPS IN THE PROPER POSITION ACCORDING TO THE DRAWING. VYAIRE HAS TAKEN THE FOLLOWING ACTIONS. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THE REPORTED ISSUE. REFERENCE MARKS WERE PLACED ON THE ASSEMBLY STATION TO ASSIST THE OPERATOR WITH CORRECT PLACEMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED "TRANSPORTING AND THE VENT HAD ¿LEAK ¿DISCONNECT ¿, BY THE TIME I GOT THERE THEY HAD SWAPPED OVER TO ANOTHER VENT. THE TEMP PROBE HAD POPPED OUT AT THE HEATER CHAMBER. LOOKING AT IT MORE I AM THINKING THE TEMP PROBE WIRE (GRAY) IS TWISTING THE TEMP PROBE, AND THE BLUE ¿V¿ IS CASING THE TEMP PROBE TO POP OUT. THE THREE WHITE TEMP PROBE WIRE KEEPERS ARE ALL CLOSE TO THE PATIENT Y. SO DURING TRANSPORT THE GRAY TEMP WIRE CAN SWING AND LOOSEN UP OR TWIST THE TEMP PROBE". CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY OR DEATH. THE PATIENT HAD A LOW SPO2 RELATED TO THE DISCONNECT. "THE TEAM STARTED BAGGING PATIENT AND SAT WENT BACK UP". "THEY DID NOT SEE THE TEMP PROBE WAS OUT AT THAT TIME, DURING TRANSPORT IT IS A TIME OF HIGH STRESS. PATIENT OK, VENT WAS CHANGED OUT WITH NEW CIRCUIT". THE LOT NUMBER IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5535 CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT OXYGEN ADMINISTRATION KIT OGL VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention