CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT
Received Nov 27, 2017 · Event occurred Nov 10, 2017
Report 8030673-2017-00385 · MDR key 7060991
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
SINCE NO SAMPLE WAS RECEIVED FROM THE CUSTOMER A COMPLETE EVALUATION OF THE DEFECTIVE SAMPLE WAS NOT POSSIBLE TO PERFORM. THE DHR HAS IDENTIFIED THAT A DEFECTIVE CRIMPING CAN POTENTIALLY CAUSE BAD ELECTRICAL CONNECTION OF THE HEATING WIRE TO THE POWER SUPPLY AND THEREFORE GENERATE RAIN OUT IN THE CIRCUIT. BASED ON THE INVESTIGATION IT IS CONSIDERED THAT THE ROOT CAUSE OF PROCESS/METHOD ERROR REPORTED IS RELATED TO THE SET-UP OF THE CRIMPING EQUIPMENT, THE CRIMPING HEIGHT CAN BE OUT OF SPEC. PREVENTIVE ACTIONS INCLUDE: QUALIFY CRIMP QUALITY MONITORS ON CRIMPER MACHINES AND RE-TRAIN PERSONNEL ON ASSEMBLY ACCORDING TO MANUFACTURE PROCEDURE.
Additional Manufacturer Narrative
INITIAL EMDR SUBMISSION: NO SAMPLE IS AVAILABLE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP SUBMISSION WILL BE FILED.
Description of Event or Problem
RESPIRATORY THERAPY HAS CHANGED HEATED WIRE CIRCUITS FOR VENTILATORS AND THE NEW CIRCUITS COLLECT WATER AND OCCLUDE THE TUBING THE PATIENT HAS TO BREATHE THROUGH.