BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE¿ X AMPLIFIER

    MDR report key: 19251140 · Received May 6, 2024

    Report

    Report Number
    2184149-2024-00084
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 8, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067034755
    PMA / PMN Number
    K231415
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 SOME PHYSICAL DAMAGE TO THE FIELD FRAME PORT, WHICH WAS CONSISTENT WITH PINS MISSING THE MATING HOLES. FOR EVALUATION PURPOSES THE PORT 3 AND PORT 4 SMALL FORM-FACTOR PLUGGABLE (SFP) WERE TEMPORARILY EXCHANGED. THE AMPLIFIER WAS POWERED ON AND THEN THE AMPLIFIER BOOTED TO A FLASHING ORANGE ¿NOT-READY¿ LIGHT EMITTING DIODE (LED) STATUS. THIS INDICATED THE AMPLIFIER DID NOT PASS THE POWER-ON-SELF-TEST (POST) ALTHOUGH THE TEST STATION AND TRACKER COMMUNICATED SUCCESSFULLY, HOWEVER THERE WAS MULTIPLE SYMPTOMS ATTRIBUTED TO ¿HW:NDI:DEVICE ERROR15¿. THIS IS AN ERROR THAT RELATES TO THE SYSTEM CONTROL UNIT HAVING A POST CONDITION. WHEN THE SCU BOARD WAS TEMPORARILY REPLACED, THE AMPLIFIER PASSED POST AND WENT SOLID GREEN, STATUS ¿READY AND COMMUNICATING¿. 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. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE WAS ATTRIBUTED TO A POST CONDITION TO THE SCU BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPARK WAS NOTED ON THE AMPLIFIER. THE ENSITE X SYSTEM WAS NOT RECOGNIZING THE FIELD FRAME. THE CABLE WHICH WAS CONNECTED TO THE FRAME WAS JIGGLED AND A SPARK WAS VISIBLE. A HARDWARE ERROR MESSAGE WAS THEN NOTED ON THE SYSTEM. AFTER THAT, THE DWS NO LONGER RECOGNIZED THE AMPLIFIER, AND A FLASHING ORANGE LIGHT WAS NOTED. THE ENSITE X AMPLIFIER (SN: (B)(6) WAS REPLACED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591020 ENSITE¿ X AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. ENSITE-AMP-02 9057134 05415067034755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown