WESTMED, DISPOSABLE ANESTHESIA CIRCUIT

Additional Manufacturer Narrative

H6: (APPROPRIATE HEALTH IMPACT TERM/CODE NOT AVAILABLE): INVESTIGATION FINDINGS- - A PROBABLE CAUSE OF THE FAILURE MAY BE TRACED TO AN ISSUE WITH THE WELDING EQUIPMENT. H6: (APPROPRIATE HEALTH IMPACT TERM/CODE NOT AVAILABLE): INVESTIGATION CONCLUSION- A PROBABLE CAUSE OF THE FAILURE MAY BE TRACED TO AN ISSUE WITH THE WELDING EQUIPMENT. NO PHOTOS, VIDEOS, OR SAMPLES WERE PROVIDED BY THE REPORTER; HOWEVER, THE REPORT OF, THE FILTER CAME APART FROM THE RESPIRATORY PORT, IS CONFIRMED; IT IS LIKELY THE EQUIPMENT IS RELATED TO THE DEFECT AND THE FAILURE IS DUE TO AN ISSUE WITH THE WELDING EQUIPMENT. THE DEVICE HISTORY RECORD FOR LOT 0004290325 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 24 DEC 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT -(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

Description of Event or Problem

SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3000219639-2024-00125 FOR THE FIRST REPORT. REFER TO 3000219639-2024-00126 FOR THE SECOND REPORT. IT WAS REPORTED, THE FILTER PASSED THE INITIAL LEAK TEST; HOWEVER, DURING PATIENT USE (UNDER ANESTHESIA) THE FILTER CAME APART FROM THE RESPIRATORY PORT. THERE WAS NO REPORTED INJURY.

Description of Event or Problem

SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3000219639-2024-00125 FOR THE FIRST REPORT. REFER TO 3000219639-2024-00126 FOR THE SECOND REPORT. IT WAS REPORTED, THE FILTER PASSED THE INITIAL LEAK TEST; HOWEVER, DURING PATIENT USE (UNDER ANESTHESIA) THE FILTER CAME APART FROM THE RESPIRATORY PORT. THERE WAS NO REPORTED INJURY.

Additional Manufacturer Narrative

THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 07 NOV 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT - (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.