MAUDE Adverse Event Report: QUALITY ELECTRODYNAMICS, LLC QUALITY ELECTRODYNAMICS; 3T 18CH KNEE COIL

Model Number	Q7000074
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: QUALITY ELECTRODYNAMICS
• Common Device Name: 3T 18CH KNEE COIL
• Manufacturer (Section D): QUALITY ELECTRODYNAMICS, LLC; 6655 beta drive suite 100; mayfield village, oh
• MDR Report Key: 9903853
• Report Number: 3007350713-2020-03311
• Device Sequence Number: 16827442
• Product Code: MOS
• UDI-Device Identifier: 00814848020003
• UDI-Public: 010081484802000311180329
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Q7000074
• Device Catalogue Number: QED000074
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Weight: 69