INFANT HEATED WIRE CIRCUIT
Received Aug 8, 2018 · Event occurred Jun 24, 2018
Report 8030673-2018-00010 · MDR key 7761739
Device
Generic name
Oxygen Administration Kit
Manufacturer
Vyaire MedicalCatalog number
AH265
Lot number
0001119873
Product problems
- Moisture or Humidity Problem
- Moisture or Humidity Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
OTHER-AT THIS TIME, THE SUSPECT COMPONENT IS NOT AVAILABLE FOR RETURN. DUE TO THE PART NOT BEING AVAILABLE TO BE RETURNED, NO FURTHER EVALUATION CAN BE COMPLETED AT THIS TIME.
Description of Event or Problem
THE RESPIRATORY THERAPIST REPORTED: EXCESSIVE RAIN-OUT.
Additional Manufacturer Narrative
THE DEVICE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BY OUR QUALITY TEAM. HOWEVER, THE QUALITY TEAM IDENTIFIED THAT A DEFECTIVE CRIMPING COULD CAUSE BAD ELECTRICAL CONNECTION OF THE HEATING WIRE TO THE POWER SUPPLY. THIS COULD GENERATE RAIN OUT IN THE CIRCUIT. IF SET UP TO CRIMPING EQUIPMENT IS NOT PROPERLY DONE, THE CRIMPING HEIGHT CAN BE OUT OF SPEC. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN VYAIRE.