BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA SYNERGY

    MDR report key: 18484902 · Received January 10, 2024

    Report

    Report Number
    3015232217-2024-00004
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    November 28, 2023
    Report Date
    June 18, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    05060191071505
    PMA / PMN Number
    K210500
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 CORRECTED. THE UDI FOR THIS PRODUCT SHOULD HAVE BEEN UDI (B)(4) WITH SERIAL NUMBER (B)(6). SECTION G4: 510 K NUMBER CORRECTED. SECTION H4: MANUFACTURER DATE ADDED. THIS IS A FOLLOW-UP TO THE FINAL REPORT SUBMITTED ON 17 APRIL 2024 TO NOTIFY THAT THE PRODUCT INFORMATION HAS BEEN UPDATED. .

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE HOSPITAL REPORTED THAT WHILE USING THE LINAC, THE MLC WAS NO LONGER RECOGNIZED. WHEN THE HOSPITAL STAFF ENTERED THE TREATMENT ROOM, THERE WAS A STRANGE SMELL. THE ISSUE HAPPENED DURING INSPECTION AND THERE WAS NO PATIENT ON THE TABLE. AFTER NOTICING THE STRANGE SMELL, THE HOSPITAL CONTACTED ELEKTA'S CARE SUPPORT CENTRE AND A FIELD SAFETY ENGINEER ARRIVED ON SITE. THERE WAS BURNOUT AROUND THE BENDING MAGNET AND FLIGHT TUBE. IT WAS FOUND THAT THERE WAS WATER LEAKAGE FROM THE COOLING PIPING OF THE BENDING MAGNET. THE FIELD SAFETY ENGINEER REPLACED THE BENDING MAGNET AND FLIGHT TUBE PARTS. THE LINAC HAS A BENDING OT INTERLOCK TO GIVE AN INHIBIT TO THE MACHINE TO RADIATE. IF THE COIL IS OVERHEATING, WATER TEMPERATURE OR THE WATER PRESSURE INTERLOCKS IF THERE IS NOT ENOUGH WATER OR IT IS TOO HOT TO THE COOLING SYSTEM. THE CUSTOMER RAISED THE CASE FEW MONTHS LATER AFTER THE INCIDENT HAPPENED THEREFORE THE SDD LOGS ARE NOT AVAILABLE TO CHECK IF THE INHIBIT WAS DISPLAYED ON THE MONITOR. IN CASE OF FIRE, IT IS STATED IN THE 'SITE PLANNING ENVIRONMENTAL INFORMATION' MANUAL THAT A CO2 FIRE EXTINGUISHER SHOULD BE PRESENT IN THE TREATMENT ROOM, CONTROL AREA AND WATER COOLER AREA TO DEAL WITH ELECTRICAL FIRES. IT IS ALSO STATES THAT THE HOSPITAL SHOULD INSTALL SMOKE DETECTORS IN THE TREATMENT ROOM. THE HOSPITAL WAS FOLLOWING THIS AS THERE WERE FIRE EXTINGUISHERS AND SMOKE ALARMS PRESENT. THE ROOT CAUSE FOR THIS ISSUE HAS NOT BEEN IDENTIFIED AS THE SDD LOGS WERE NOT AVAILABLE. IT IS LIKELY POSSIBLE TO BE A BURNOUT AS THERE WAS NOT ENOUGH COOLING IN THE BENDING COIL BUT THIS SHOULD HAVE BEEN DETECTED BY THE INTERLOCK. THE ISSUE OF BURNOUT IS A KNOWN RISK (SEVERITY "NON-SERIOUS" AND PROBABILITY "INCREDIBLE") AND THE RISK ASSESSMENT CONCLUDED THAT THE RISK IS LOW.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED BENDING MAGNET FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538059 ELEKTA SYNERGY ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 05060191071505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown