BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE¿ X AMPLIFIER

    MDR report key: 23790349 · Received December 12, 2025

    Report

    Report Number
    2184149-2025-00198
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 13, 2025
    Report Date
    January 16, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQK
    UDI-DI
    05415067034755
    PMA / PMN Number
    K242016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ENSITE X AMPLIFIER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE FRONT PORTS AND CHASSIS SHOW SIGNS OF WEAR CONSISTENT WITH USE OVER TIME. VISUAL INSPECTION OF THE REAR PANEL PORTS IDENTIFIED THAT THE ETHERNET SMALL FORM-FACTOR PLUGGABLE (SFP) WAS MISSING UPON RETURN. FOR EVALUATION PURPOSES THE PORT 3 AND PORT 4 SMALL FORM-FACTOR PLUGGABLE (SFP) WERE TEMPORARILY EXCHANGED AND INSTALLED. THE AMPLIFIER WAS POWERED ON AND THEN THE AMPLIFIER BOOTED TO A BLINKING AMBER ¿NOT-READY¿ LIGHT EMITTING DIODE (LED) STATUS. THIS INDICATED THE AMPLIFIER DID NOT PASS THE POWER-ON-SELF-TEST (POST) ALTHOUGH COMMUNICATED WITH THE TEST STATION TRACKER SOFTWARE. THE AMPLIFIER LOGS IDENTIFIED A STIM STEERING FAULT. THIS SYMPTOM WAS ISOLATED TO THE SURFACE CARD, BY TEMPORARY REPLACEMENT. THE FIELD REPORTED EVENT WAS ABLE TO BE DUPLICATED BY POWER SEQUENCING. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE REPORTED EVENT WAS ABLE TO BE CONFIRMED, AND THE ROOT CAUSE WAS ATTRIBUTED TO THE SURFACE CARD. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED.

    Description of Event or Problem · 0

    DURING A RF PREMATURE VENTRICULAR CONTRACTION PROCEDURE, CONNECTION BETWEEN THE ENSITE X AMPLIFIER TO THE DISPLAY WORKSTATION COULD NOT BE ESTABLISHED AND THE LIGHT WAS FLASHING GREEN RESULTING IN A DELAY. THE PORTS AND FIBER OPTIC CONNECTIONS WERE CHECKED. RESTARTING THE AMPLIFIER RESULTED IN AN ORANGE BLINKING STATUS LIGHT. THIS TROUBLESHOOTING WAS REATTEMPTED MULTIPLE TIMES WITH NO RESOLVE. THE CONNECTIONS AT THE FRONT OF THE AMPLIFIER WERE DISCONNECTED, THE FIBER OPTIC CABLES WERE EXCHANGED, AND THE DISPLAY WORKSTATION AND AMPLIFIER WERE RESTARTED MULTIPLE TIMES. AFTER MULTIPLE TRIES A CONNECTION WAS ESTABLISHED WITH THE ORIGIN CABLES. APPROXIMATELY 30 MINUTES WAS SPENT TROUBLESHOOTING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2760832 ENSITE¿ X AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ABBOTT MEDICAL ENSITE-AMP-02 9155536 05415067034755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown