BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 FOOT DISPOSABLE EXTENSION CABLES WITH SAFE CONNECT/SCREW-DOWN

    MDR report key: 24594368 · Received March 13, 2026

    Report

    Report Number
    1056553-2026-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Report Date
    March 12, 2026
    Manufacturer
    REMINGTON MEDICAL INC.
    Product Code
    DSA
    PMA / PMN Number
    K971968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDSUN REPORT WAS RECEIVED ON 02 MAR 2026 FROM THE FDA. THIS WAS NOT REPORTED TO REMINGTON MEDICAL BY YALE-NEW HAVEN HOSPITAL. THE SUSPECT DEVICE WAS NOT RETURN TO REMINGTON MEDICAL TO CONFIRM A MALFUNCTION OR TO DO A PROPER EVALUATION AND INVESTIGATION. NO LOT NUMBER WAS PROVIDED. NO OTHER COMPLAINT HAS BEEN RECEIVED FOR THE PRODUCT CODE LISTED ABOVE (FL-601-97-B).

    Description of Event or Problem · 0

    PATIENT WITH TEMPORARY PACING VIA EPICARDIAL WIRES EXPERIENCED ASYSTOLE REQUIRING CPR AND EPINEPHRINE TO BE PROVIDED. ROSC [RETURN OF SPONTANEOUS CIRCULATION] WAS OBTAINED AND PACER WAS ON AND SET FOR BACK UP, IT WAS CONFIRMED TO BE OPERATIONAL (CAPTURING AND SENSING) EARLIER IN THE DAY. POST CODE IT APPEARED THE PINS CONNECTED TO THE PACING BOX WERE LOOSE. THE LOOSE CONNECTIONS ARE OCCURRING REGULARLY NOW, WITH LATEST EVENT [REDACTED]. THIS IS OCCURRING WITH STAFF THAT ARE VERY SEASONED AS WELL AS NEWER STAFF. CONNECTIONS ARE BEING CHECKED ACCORDING TO PRACTICE GUIDELINES. THE NURSE EDUCATOR WHO HAS BEEN IN THE UNIT SINCE PRIOR TO THE CONVERSION TO THESE DISPOSABLE CONNECTORS APPROXIMATELY 15 YEARS AGO SAID THERE HAS BEEN A MARKED INCREASE IN DISCONNECTIONS FROM THE PATIENT WIRES, AS THOUGH THE BARRELS ARE STARTING TO FAIL TO GRASP THE PATIENT WIRES AS SUCCESSFULLY. THE DISCONNECTIONS ARE HAPPENING INSIDE THE BARREL OF THE RED AND BLACK CONNECTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659901 6 FOOT DISPOSABLE EXTENSION CABLES WITH SAFE CONNECT/SCREW-DOWN CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) DSA REMINGTON MEDICAL INC. ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other