CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT

Additional Manufacturer Narrative

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

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

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".