INFANT HEATED WIRE CIRCUIT

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

THE RESPIRATORY THERAPIST REPORTED: RAIN-OUT IS A BIG PROBLEM ON INTUBATED BABY. DRAINING CIRCUIT VERY FREQUENTLY. RAIN -OUT IS SETTING OFF HIGH RESPIRATION RATE ALARM. CONNECTION AT THE SWIVEL FALLS OUT EASILY.

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.