AIRLIFE
Received Aug 27, 2025
Report 1314417-2025-00061 · MDR key 22908982
Device
Product problems
- Temperature Problem
- Temperature Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
CORRECTION: D9. ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: D4; H2; H6. THE ACTUAL SAMPLE, FROM THE REPORTED EVENT WAS RETURNED AND EVALUATED, NO ISSUES WERE OBSERVED ON DEVICE. SINCE THE REPORTED FAILURE WAS NOT REPRODUCED IN THE LAB DURING SAMPLE EVALUATION; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 0004321947 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 02 OCT 2025 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
IT WAS REPORTED, TEMPERATURE FLUCTUATION WAS NOTICED AS SOON AS THE DEVICE WAS PLACED ON THE PATIENT; THE FLUCTUATION WAS MONITORED FOR SEVERAL MINUTES AND AFTERWARD TROUBLESHOOTING WAS PERFORMED. THE ISSUE WAS CORRECTED ONLY WHEN THE CIRCUIT WAS CHANGED. THERE WAS NO REPORTED INJURY TO THE PATIENT.
Additional Manufacturer Narrative
THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 27 AUG 2025 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 (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
IT WAS REPORTED, TEMPERATURE FLUCTUATION WAS NOTICED AS SOON AS THE DEVICE WAS PLACED ON THE PATIENT; THE FLUCTUATION WAS MONITORED FOR SEVERAL MINUTES AND AFTERWARD TROUBLESHOOTING WAS PERFORMED. THE ISSUE WAS CORRECTED ONLY WHEN THE CIRCUIT WAS CHANGED. THERE WAS NO REPORTED INJURY TO THE PATIENT.