SUN MED

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 09 MAY 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, THE PEDIATRIC PATIENT EXPERIENCED A DELAY IN CARE DUE TO THE MIS-ASSEMBLY OF THE DEVICE (THE BAG WAS ON THE PORT FOR THE MASK AND VICE VERSA). THE MEDICAL TEAM GAVE THE BABY BLOW BY WHILE A DIFFERENT DEVICE WAS SOURCED. THERE WAS NO REPORTED INJURY.

Description of Event or Problem

IT WAS REPORTED, THE PEDIATRIC PATIENT EXPERIENCED A DELAY IN CARE DUE TO THE MIS-ASSEMBLY OF THE DEVICE (THE BAG WAS ON THE PORT FOR THE MASK AND VICE VERSA). THE MEDICAL TEAM GAVE THE BABY BLOW BY WHILE A DIFFERENT DEVICE WAS SOURCED. THERE WAS NO REPORTED INJURY.

Additional Manufacturer Narrative

CORRECTION: D3. ADDITIONAL INFORMATION-INVESTIGATION CONCLUSION: D4; H2; H6. THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE FAILURE MODE WAS INVESTIGATED AND THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED; PROCESSES AND PROCEDURES ARE IN PLACE TO PREVENT ITS REOCCURRENCE, WHICH INCLUDES IMPROVEMENTS TO THE FINAL ASSEMBLY FIXTURE AND STAFF RETRAINING. THE DEVICE HISTORY RECORD FOR LOT 491078 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 08 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 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.