AIRLIFE¿ INFANT HEATED WIRE CIRCUIT
Received Aug 8, 2018 · Event occurred Jun 24, 2018
Report 8030673-2018-00009 · MDR key 7762847
Device
Product problems
- Moisture or Humidity Problem
- Moisture or Humidity Problem
Patient
Not reported
- Increased Respiratory Rate
- Increased Respiratory Rate
Narrative
Additional Manufacturer Narrative
AT THIS TIME, VYAIRE MEDICAL HAS NOT RECEIVED THE SAMPLE FOR INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
FELLOW M.D. REPORTED: TOO MUCH RAIN-OUT CAUSING VENT TO REGISTER HIGH RESPIRATORY RATE. ASKED TO HAVE CIRCUIT CHANGED OUT.
Additional Manufacturer Narrative
CODE 81 OTHER: 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 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.