MAUDE Adverse Event Report: QUALITY ELECTRODYNAMICS, LLC CONTOUR 24; MRI RF COIL

Model Number	Q7000183
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Quality electrodynamics received a complaint forwarded from siemens that a contour 24 rf coil caused a patient burn.The burn was on backside of right wrist and was a dime - nickel sized blister.The patient was wearing scrubs provided by the hospital and was not sedated.The patient did not request that the scan be stopped.The patient chose not to seek additional medical care for the burn.The contour coil was being used by itself (with no other coils) and was positioned over the patient's pelvic region.Per the technologist's memory: 1.There were no pads between the patients legs.2.There was padding between the coil and bore.3.It is unknown if there were pads between the patient' hips and arms.4.It is unknown if there were pads between the patient's hand and the coil, but the technician stated that the patient's hand was not contacting the coil at the beginning of the scan.It is believed that the patient may have inadvertently shifted her/the coil's position during the scan, which could have caused the hard housing of the coil to contact her wrist resulting in the burn.The coil was returned to siemens and subsequently to quality electrodynamics after the incident.

• Brand Name: CONTOUR 24
• Common Device Name: MRI RF COIL
• Manufacturer (Section D): QUALITY ELECTRODYNAMICS, LLC; 6655 beta drive suite 100; mayfield village OH 44143
• Manufacturer (Section G): QUALITY ELECTRODYNAMICS, LLC; 6655 beta drive suite 100; mayfield village OH 44143
• Manufacturer Contact: kathleen aras ; 6655 beta drive suite 100; mayfield village, OH 44143 ; 4404842964
• MDR Report Key: 17191593
• Report Number: 3007350713-2023-06191
• Device Sequence Number: 12587717
• Product Code: MOS
• UDI-Device Identifier: 00814848020423
• UDI-Public: 0100814848020423112210030
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K183111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Q7000183
• Device Catalogue Number: Q7000183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 54 KG