BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE¿ X AMPLIFIER

    MDR report key: 22849120 · Received August 20, 2025

    Report

    Report Number
    2184149-2025-00143
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    July 21, 2025
    Report Date
    October 8, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQK
    UDI-DI
    05415067034748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ENSITE X AMPLIFIER WAS RECEIVED FOR EVALUATION. FOR EVALUATION PURPOSES THE PORT 3 AND PORT 4 SMALL FORM-FACTOR PLUGGABLE (SFP) WERE TEMPORARILY EXCHANGED. THE AMPLIFIER WAS POWERED ON AND 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) AND COULD NOT COMMUNICATE WITH THE TEST STATION TRACKER SOFTWARE. THE SERVICE TOOL WAS CONNECTED AND BOOTED INTO A PUTTY INTERFACE, WHICH IDENTIFIED MULTIPLE ERRORS. ADDITIONALLY, THE AUDIBLE BOOT OCCURRED APPROXIMATELY 6 TIMES; 2 IS NORMAL. TEMPORARY REPLACEMENT OF THE SENSOR INTERFACE UNIT (SIU) DID NOT ALLEVIATE THE SYMPTOM. REPLACEMENT OF THE SENSOR CONTROL UNIT RESOLVED THE MAGNETIC BOOT CONDITION. 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 REPORTED EVENT WAS ABLE TO BE CONFIRMED, AND THE ROOT CAUSE WAS ATTRIBUTED TO THE SCU.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3, H6, H11. ONE ENSITE X AMPLIFIER WAS RECEIVED FOR EVALUATION. FOR EVALUATION PURPOSES THE PORT 3 AND PORT 4 SMALL FORM-FACTOR PLUGGABLE (SFP) WERE TEMPORARILY EXCHANGED. THE AMPLIFIER WAS POWERED ON AND 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) AND COULD NOT COMMUNICATE WITH THE TEST STATION TRACKER SOFTWARE. THE SERVICE TOOL WAS CONNECTED AND BOOTED INTO A PUTTY INTERFACE, WHICH IDENTIFIED MULTIPLE ERRORS. ADDITIONALLY, THE AUDIBLE BOOT OCCURRED APPROXIMATELY 6 TIMES; 2 IS NORMAL. TEMPORARY REPLACEMENT OF THE SENSOR INTERFACE UNIT (SIU) DID ALLEVIATE THE SYMPTOM. REPLACEMENT OF THE SENSOR CONTROL UNIT RESOLVED THE MAGNETIC BOOT CONDITION. FURTHER INFORMATION WAS DELIVERED TO INVESTIGATIONS BY MEANS OF THE SERVICE EVALUATION LOG (SEL). AFTER REPLACEMENT OF THE SCU, DURING CALIBRATION. THIS CALIBRATION SYMPTOM WAS ISOLATED TO CHANNEL 41 (CHANNEL 1 OF SLOT 1) CARDIAMP BOARD AND FRONT PLANE ASSEMBLY. AFTER BOTH WERE REPLACED A TEST STATION CONDITION WAS ENCOUNTERED, FOLLOWED BY A GPIO, WHICH PER REWORK DOCUMENTS WERE RETESTED AND PASSED SUCCESSFULLY. THE CALIBRATION AND FUNCTIONAL CHANNEL FAILURES WERE DETERMINED TO BE NOT RELATED TO THE REPORTED SYMPTOM. THE FIELD REPORTED EVENT WAS ABLE TO BE DUPLICATED BY POWER SEQUENCING. 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 REPORTED EVENT WAS ABLE TO BE CONFIRMED, AND THE ROOT CAUSE WAS ATTRIBUTED TO THE SCU.

    Description of Event or Problem · 0

    THE AMPLIFIER DID NOT PASS THE SELF-TEST WHICH CAUSED A DELAY IN PROCEDURE. AT THE START OF THE CASE, AFTER PATCHING THE PATIENT, AN ERROR WAS NOTED STATING: "AMPLIFIER HARDWARE ERROR DETECTED" AND "UNABLE TO DETECT MAGNETIC FIELD" AND THE AMPLIFIER WENT TO FLASHING ORANGE. MULTIPLE REBOOTS OF THE AMPLIFIER AND DWS WERE PERFORMED, REBOOTS WITH CABLES DISCONNECTED, AND A REBOOT WITH ONLY THE POWER CABLE CONNECTED, HOWEVER, THE AMPLIFIER STILL BOOTED TO A FLASHING ORANGE LIGHT. ANOTHER AMPLIFIER WAS RETRIEVED FROM ANOTHER HOSPITAL (30 MINUTES) WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373855 ENSITE¿ X AMPLIFIER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ABBOTT MEDICAL ENSITE-R-AMP-02 10607016 05415067034748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown