BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUALITY ELECTRODYNAMICS

    MDR report key: 9903853 · Received March 31, 2020

    Report

    Report Number
    3007350713-2020-03311
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    January 30, 2020
    Report Date
    March 31, 2020
    Manufacturer
    QUALITY ELECTRODYNAMICS, LLC
    Product Code
    MOS
    UDI-DI
    00814848020003
    PMA / PMN Number
    K150331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY ROOT CAUSE OF THE BURN WAS DUE TO USER ERROR, NAMELY LACK OF PADS PLACED IN BETWEEN THE LEGS OR BETWEEN THE HAND/ARM AND LEG AS REQUIRED BY THE USER MANUAL WHICH CAUSED EXCESSIVE POWER DEPOSITION IN LOCALIZED ANATOMY. THE COIL HAS REMAINED IN USE SINCE THE (B)(6) 2020 INCIDENT DATE WITH NO OBSERVED ISSUES. NO ADDITIONAL ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A BURN AFTER A KNEE EXAM USING A 3T 18CH KNEE COIL WITH A GE 3.0T SIGNA ARCHITECT MRI SYSTEM. THE BURN WAS 2-3 INCHES IN DIAMETER, WITH REDNESS AND FORMED A BLISTER AFTER PATIENT LEFT THE SITE. BURN WAS >75% PARTIAL THICKNESS. PATIENT WAS SEEN BY A PHYSICIAN AND DIAGNOSED WITH A SECOND DEGREE BURN WHICH WAS TREATED WITH FIRST AID AND OINTMENT. BURN WAS HEALING WITHOUT FURTHER MEDICAL TREATMENT. PATIENT HAD A KNEE EXAM ON (B)(6) 2020 AND SENT A LETTER TO THE MRI FACILITY ON 13 FEBRUARY 2020 STATING THAT SHE EXPERIENCED A BURN ON HER RIGHT KNEE. THE PATIENT STATED SHE FELT WARMTH AND TINGLING DURING THE EXAM BUT CONTINUED THE EXAM. GE (THE MR SYSTEM MANUFACTURER) WAS NOTIFIED OF THE BURN BY THE MEDICAL FACILITY AND THEN THEY SUBSEQUENTLY NOTIFIED QED ON 05 MAR 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370250 QUALITY ELECTRODYNAMICS 3T 18CH KNEE COIL MOS QUALITY ELECTRODYNAMICS, LLC Q7000074 00814848020003

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other