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Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, THE PATIENT'S HEART RATE REMAINED STABLE AT 60-80 BEATS PER MINUTE; HOWEVER, THE ELECTROCARDIOGRAM (ECG) MONITOR INTERMITTENTLY DISPLAYED VALUES AROUND 200 BPM. A SECONDARY VITAL SIGNS MONITOR WAS USED CONCURRENTLY, AND NO SAFETY ISSUES OCCURRED FOR THE PATIENT. THE ISSUE APPEARED TO BE RELATED TO A POOR CABLE CONNECTION NEAR THE ECG CONNECTOR ON THE DEVICE SIDE.

Additional Manufacturer Narrative

THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED FOR EVALUATION, AND NO PHOTOGRAPHIC OR VIDEOGRAPHIC EVIDENCE WAS PROVIDED. IN THE ABSENCE OF VISUAL DOCUMENTATION, THE COMPLAINT COULD NOT BE CONFIRMED; FURTHERMORE, WITHOUT A SAMPLE FOR FUNCTIONAL TESTING, THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 12 DEC 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 INFORMATION KNOWN 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 A SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.