BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT

    MDR report key: 7011686 · Received November 8, 2017

    Report

    Report Number
    8030673-2017-00377
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    October 9, 2017
    Report Date
    February 21, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    OGL
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY IT HAS BEEN CONFIRMED THAT THE SAMPLE WAS LOST IN TRANSIT FROM THE DECONTAMINATION FACILITY. ADDITIONAL INFORMATION: UNFORTUNATELY THE REPRESENTATIVE SAMPLES WERE NOT AVAILABLE FOR FURTHER EVALUATION SO THE FAILURE AND ROOT CAUSE COULD NOT BE CONFIRMED. IT HAS BEEN IDENTIFIED THAT A DEFECTIVE CRIMPING IN THE HEATER WIRE CAN POTENTIALLY CAUSE A BAD ELECTRICAL CONNECTION OF HEATING WIRE TO THE POWER SUPPLY AND THEREFORE GENERATE RAIN OUT IN THE CIRCUIT. DUE TO THIS POTENTIAL FAILURE A CAPA HAS BEEN INITIATED WITH THE FOLLOWING CONTAINMENT ACTIONS HAVE BEEN PERFORMED. VYAIRE IS DOING INSPECTION FOR 200% FOR WIRE RESISTANCE TO ENSURE CIRCUITS ARE FUNCTIONAL. INSPECTION FOR CORRECT WIRE RETAINER POSITION IS ALSO BEING PERFORMED. THE FOLLOWING PREVENTIVE ACTIONS ARE BEING IMPLEMENTED VYAIRE IS QUALIFYING CRIMP QUALITY MONITORS ON THE CRIMPER MACHINES, AND PERSONNEL ARE BEING RETRAINED ON THE ASSEMBLY PROCEDURE.

    Additional Manufacturer Narrative · 1

    VYAIRE HAS RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE DEVICE HAS BEEN PROCESSED THROUGH VYAIRE'S DECONTAMINATION PROCESS AND HAS BEEN SHIPPED OUT TO THE MANUFACTURING FACILITY FOR FURTHER ANALYSIS. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VENT CIRCUIT EXPERIENCING EXCESSIVE RAIN OUT. THERE IS NO A/C BLOWING DIRECTLY ON THE PATIENT. NO FAN. THE RAIN OUT IS ON THE EXPIRATORY SIDE. THE PATIENT HAS BEEN ON THE VENT 6 DAYS. TEMP PROBES WERE FULLY INSERTED AND UPRIGHT. "THE PATIENT DID BECAME TACHYPNEIC AND APPEARED TO BE FAILING HER WEAN. HOWEVER, UPON FURTHER INSPECTION I FOUND ONCE THE RAINOUT WAS REMOVED FROM THE TUBE PATIENT TACHYPNEIC RESOLVED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790289 CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT OXYGEN ADMINISTRATION KIT OGL VYAIRE MEDICAL, INC 0001129069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention