CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT
Received Oct 6, 2017 · Event occurred Sep 5, 2017
Report 8030673-2017-00371 · MDR key 6921454
Device
Product problems
- Moisture or Humidity Problem
- Moisture or Humidity Problem
Patient
Not reported
- Exposure to Body Fluids
- Exposure to Body Fluids
Narrative
Additional Manufacturer Narrative
THE SAMPLE WAS NOT RECEIVED AND WAS LOST IN TRANSIT. 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
(B)(4). VYAIRE HAS RECEIVED A REPRESENTATIVE SAMPLE FROM THE SAME LOT NUMBER FOR FURTHER EVALUATION. VYAIRE IS CURRENTLY PERFORMING AN INVESTIGATION INTO THE REPORTED ISSUE. A FOLLOW UP MDR WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
THE CUSTOMER REPORTED "TONS OF RAIN-OUT OBSERVED WITH HEATED SYSTEM. WHEN EXTUBATING THE PATIENT THE VENT TUBING BECAME DISLODGED AND THE WATER SPRAYED INTO MY FACE". RESPIRATORY THERAPIST WENT TO THE ER FOR FURTHER EVALUATION.