BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM SPECTRA

    MDR report key: 13900345 · Received March 25, 2022

    Report

    Report Number
    3004754211-2022-20064
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    March 13, 2022
    Report Date
    March 25, 2022
    Manufacturer
    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
    Product Code
    LNH
    UDI-DI
    04056869006796
    PMA / PMN Number
    K153447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ASSESSMENT DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. IT WAS REPORTED THAT A PATIENT SUSTAINED BLISTERS ON HER ABDOMEN AFTER SPINE SCANNING. THE MR SYSTEM HAS BEEN CHECKED. NO SYSTEM MALFUNCTION WAS FOUND, AND THE SYSTEM WORKS NORMALLY. THE PATIENT HAD NO TATTOOS, THERE WAS NO SAR MESSAGE POP-UP DURING THE SCANNING, AND IT WAS CONFIRMED THAT THE SQUEEZE BALL IS IN GOOD CONDITION BEFORE AND DURING THE EXAMINATION. THE SPECIFIC ENERGY DOSE IN THIS CASE IS 3,037.2 J/KG. IT IS FAR BELOW THE LIMIT OF 14,400 J/KG FROM IEC 60601-2-33 "PARTICULAR REQUIREMENTS FOR THE SAFETY OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS". THE FINAL SED VALUE (3,037.2 J/KG )WAS A LITTLE BIT HIGH, WHICH COULD MAKE PATIENT FEEL HOT. BASED ON THE ANALYSIS, SAR MONITORING WORKED WELL DURING THE EXAMINATION AS ALL SYSTEM TESTS PASSED. THE SAR VALUE WAS WELL BELOW THE LIMIT FROM THE SAFETY STANDARD; THEREFORE, THIS EXAM FULFILLED THE SAFETY REQUIREMENT. THE PATIENT WORE HER CLOTHES WITH UNKNOWN MATERIAL DURING THE SCANNING. WE CANNOT CONFIRM WHETHER THERE IS ANY METAL MATERIAL IN HER CLOTHES. THE SAFETY REQUIREMENTS IN OPERATOR MANUAL OF MAGNETOM SPECTRA (DOC ID: (B)(6) ON PAGE 21) DESCRIBE THE CAUTION OF PATIENT WEARING AND POSITIONING IN CASE OF THE FORMATION OF ELECTRIC CURRENT LOOP. BASED ON THE ABOVE ANALYSIS, NO SYSTEM MALFUNCTION IS DETECTED. IN SUMMARY NO HARDWARE OR SOFTWARE PROBLEM WAS FOUND BY OUR SYSTEM THAT WOULD EXPLAIN THE PATIENT'S BURN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED FOLLOWING EXAMINATION ON THE MAGNETOM SPECTRA MR SYSTEM. FOLLOWING A SPINE SCAN, THE PATIENT COMPLAINED OF BLISTERS. THE PATIENT WAS TREATED WITH A CREAM AND NO FURTHER IMPACT TO THE PATIENT IS KNOWN. AT THIS TIME, NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED, HOWEVER, SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108463 MAGNETOM SPECTRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. 10655588 04056869006796

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown