BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK

    MDR report key: 23792097 · Received December 12, 2025

    Report

    Report Number
    3010838917-2025-00012
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 12, 2025
    Manufacturer
    AIRLIFE FINLAND OY
    Product Code
    DSA
    UDI-DI
    10889483576359
    PMA / PMN Number
    K980582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2770535 MULTI-LINK MULTI-LINK¿ ECG CARE CABLE, 3/5-LEAD WITH ESU FILTER, IEC, 3.6M / 12FT DSA AIRLIFE FINLAND OY 2022948-002 UNKNOWN 10889483576359

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown