BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOTLIGHT

    MDR report key: 21633179 · Received March 18, 2025

    Report

    Report Number
    3010642685-2025-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 18, 2025
    Manufacturer
    ARINETA LTD.
    Product Code
    JAK
    UDI-DI
    07290016484007
    PMA / PMN Number
    K230370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE THE REPORTED PROBLEM WAS RESOLVED BY REPLACING THE AC/DC POWER SUPPLY UNIT AND THE RELEVANT SLIP RING BRUSH BLOCKS, CLEANING THE SLIP RING SURFACE, AND CONDUCTING A FULL PREVENTIVE MAINTENANCE (PM) ON SITE TO RETURN THE SYSTEM TO A BASELINE OPERATIONAL CONDITION. THIS BROUGHT THE SYSTEM BACK TO CLINICAL OPERATION FOLLOWING COMPLETE SERVICE AND SAFETY TESTING. THE SUPPLIER OF THE AC/DC UNIT CONDUCTED A DETAILED ANALYSIS OF THE RETURNED HARDWARE. THE EVALUATION DETERMINED THAT ABB CONTACTOR K1 HAD ITS T1 AND T3 CONTACTS WELDED IN THE CLOSED POSITION DUE TO AN EXTERNAL VOLTAGE/CURRENT TRANSIENT. AS A RESULT, CURRENT FLOWED INTO THE RESISTOR DUMP CIRCUIT, CAUSING OVERHEATING OF RESISTORS R7, R9, R22, AND R23. THIS LED TO MELTING AND PARTIAL BURNING OF EIGHT (8) PANDUIT CABLE TIES LOCATED IN CLOSE PROXIMITY TO THE RESISTORS. NO FURTHER DAMAGE WAS OBSERVED WITHIN THE UNIT. NO FLAME PROPAGATION OR EXTERNAL FIRE OCCURRED. VISUAL DAMAGE WAS OBSERVED ON THE SLIP RING INSIDE THE GANTRY. INSPECTION REVEALED ARCING MARKS AND MECHANICAL WEAR ON THE SLIP RING SURFACE. THE SLIP RING MANUFACTURER CONFIRMED THE COMPONENT REMAINS ELECTRICALLY FUNCTIONAL AND SAFE FOR CLINICAL USE. THE INSUFFICIENT CONTACT BETWEEN THE SLIP RING AND BRUSH BLOCKS DUE TO WEAR, POOR SEATING, OR CONTAMINATION RESULTED IN INTERMITTENT HIGH-VOLTAGE DISCHARGE, WHICH LIKELY INITIATED THE DOWNSTREAM FAILURE IN THE AC/DC UNIT. THE AFFECTED BRUSH BLOCKS WERE REPLACED, AND THE SLIP RING WAS THOROUGHLY CLEANED AS PART OF THE FULL PM PROCESS. THE AC/DC SUPPLIER IS IMPLEMENTING A CORRECTIVE ACTION TO REPLACE PLASTIC CABLE TIES NEAR THE RESISTOR DUMP CIRCUIT WITH THERMALLY RESISTANT ALTERNATIVES. ADDITIONALLY, ARINETA IS INTRODUCING A PROCEDURAL REQUIREMENT TO PERFORM FULL PREVENTIVE MAINTENANCE INSPECTIONS DURING SYSTEM UPGRADES (IN ADDITION TO THE REGULAR PREVENTIVE MAINTENANCE PROCEDURE) WHICH INCLUDES BRUSH BLOCK INSPECTION AND REPLACEMENT IF NEEDED, SLIP RING CLEANING IF NEEDED, CONTACT VERIFICATION, AND OVERALL GANTRY ALIGNMENT TO ENSURE A RETURN TO BASELINE OPERATIONAL CONDITION BEFORE CLINICAL USE. ACCORDING TO ARINETA'S RISK ASSESSMENT PROCESS, THE RISK SEVERITY IS NEGLIGIBLE ,WHICH WOULD NOT REASONABLY CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE PROBLEM WERE TO REOCCUR. NO TREND HAS BEEN IDENTIFIED IN THE INSTALLED BASE. NO SYSTEMATIC ISSUE NOR GENERAL DESIGN FLAW WAS IDENTIFIED. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED.

    Description of Event or Problem · 0

    MANUFACTURER NARRATIVE: ARINETA IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. EVENT DESCRIPTION: IT WAS REPORTED BY (B)(6) HOSPITAL, THAT SPARKS AND SMOKE WERE OBSERVED COMING FROM THE BOTTOM OF THE GANTRY COVERS DURING A PATIENT SCAN. THE SCAN PROTOCOL WAS COMPLETED WITH NO CONTRAST, AND NO HARM WAS REPORTED TO THE PATIENT. UPON FURTHER INVESTIGATION, THE FIELD ENGINEERS OPENED THE POWER DISTRIBUTION UNIT (PDU) COVERS AND DISCOVERED SMOKE COMING FROM THE AC/DC BOX. FURTHER INSPECTION OF THE GANTRY SHOWED VISUAL DAMAGE TO THE SLIP RING INSIDE THE GANTRY. THERE HAVE BEEN NO REPORTS OF ANY IMPACT TO THE HEALTH OR SAFETY OF THE PATIENT OR USER INVOLVED. ARINETA HAS REQUESTED ADDITIONAL INFORMATION TO FURTHER INVESTIGATE THE REPORTED EVENT.

    Description of Event or Problem · 0

    EVENT DESCRIPTION IT WAS REPORTED BY (B)(6) HOSPITAL THAT SPARKS AND SMOKE WERE OBSERVED COMING FROM THE BOTTOM OF THE GANTRY COVERS DURING A PATIENT SCAN. THE SCAN PROTOCOL WAS COMPLETED WITH NO CONTRAST, AND NO HARM WAS REPORTED TO THE PATIENT. UPON FURTHER INVESTIGATION, THE FIELD ENGINEERS OPENED THE POWER DISTRIBUTION UNIT (PDU) COVERS AND DISCOVERED SMOKE COMING FROM THE AC/DC BOX. FURTHER INSPECTION OF THE GANTRY SHOWED VISUAL DAMAGE TO THE SLIP RING INSIDE THE GANTRY. THERE HAVE BEEN NO REPORTS OF ANY IMPACT TO THE HEALTH OR SAFETY OF THE PATIENT OR USER INVOLVED. ARINETA HAS REQUESTED ADDITIONAL INFORMATION TO FURTHER INVESTIGATE THE REPORTED EVENT.MANUFACTURER NARRATIVE ARINETA HAS COMPLETED AN INVESTIGATION OF THE EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A HIGH-VOLTAGE TRANSIENT LIKELY ORIGINATING FROM THE GANTRY SLIP RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451910 SPOTLIGHT SPOTLIGHT JAK ARINETA LTD. 07290016484007

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male