BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT

    MDR report key: 7060991 · Received November 27, 2017

    Report

    Report Number
    8030673-2017-00385
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    November 10, 2017
    Report Date
    February 23, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    OGL
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO SAMPLE WAS RECEIVED FROM THE CUSTOMER A COMPLETE EVALUATION OF THE DEFECTIVE SAMPLE WAS NOT POSSIBLE TO PERFORM. THE DHR HAS IDENTIFIED THAT A DEFECTIVE CRIMPING CAN POTENTIALLY CAUSE BAD ELECTRICAL CONNECTION OF THE HEATING WIRE TO THE POWER SUPPLY AND THEREFORE GENERATE RAIN OUT IN THE CIRCUIT. BASED ON THE INVESTIGATION IT IS CONSIDERED THAT THE ROOT CAUSE OF PROCESS/METHOD ERROR REPORTED IS RELATED TO THE SET-UP OF THE CRIMPING EQUIPMENT, THE CRIMPING HEIGHT CAN BE OUT OF SPEC. PREVENTIVE ACTIONS INCLUDE: QUALIFY CRIMP QUALITY MONITORS ON CRIMPER MACHINES AND RE-TRAIN PERSONNEL ON ASSEMBLY ACCORDING TO MANUFACTURE PROCEDURE.

    Additional Manufacturer Narrative · 1

    INITIAL EMDR SUBMISSION: NO SAMPLE IS AVAILABLE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP SUBMISSION WILL BE FILED.

    Description of Event or Problem · 1

    RESPIRATORY THERAPY HAS CHANGED HEATED WIRE CIRCUITS FOR VENTILATORS AND THE NEW CIRCUITS COLLECT WATER AND OCCLUDE THE TUBING THE PATIENT HAS TO BREATHE THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838135 CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT OXYGEN ADMINISTRATION KIT OGL VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention