INFANT HEATED WIRE CIRCUIT
Received Aug 3, 2018 · Event occurred Jun 25, 2018
Report 8030673-2018-00004 · MDR key 7748452
Device
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
AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SAMPLE FOR INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE NURSE REPORTED EXCESSIVE WATER CONDENSATION WHILE USING THE INFANT HEATED WIRE CIRCUIT. THE NURSE OBSERVED EXCESSIVE CONDENSATION IN BOTH THE EXPIRATORY AND INSPIRATORY LIMBS AND THE BABY'S FACE IS CONSTANTLY WET REQUIRING MULTIPLE RE-TAPES. THE NURSE REPORTED THE CIRCUIT WAS CHANGED OUT AND NO PATIENT CONSEQUENCE ASSOCIATED WITH THE EVENT.
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 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.