MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MRXPERION MR INJECTION SYSTEM

Model Number	87838420
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation remains in progress.Once the investigation is completed, a follow-up report will be submitted.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Event or Problem Description
The customer reported the following: while performing a signal to noise ratio (snr) test on the medrad® mrxperion injection system (serial number (b)(6), the technologist observed that the snr result was lower than expected.Prior to repeating the test, the employee unplugged the energized power supply from the wall outlet and experienced an electrical shock sensation.In accordance with hospital protocol, the employee was evaluated in the emergency room and was subsequently discharged.The site has confirmed that the technologist has since returned to full duty with no further issues reported.
Additional Manufacturer Narrative
On december 12, 2025, bayer service visited the site and performed a functional check of the medrad® mrxperion injection system (serial number (b)(6)), including an electrical leakage test.The injection system was confirmed to be functioning to bayer specifications.Additionally, the hospital electrician tested the 110v outlet, and no issues were reported.Based on the investigation, no device malfunction was identified.The most likely cause of the reported problem is electrostatic discharge (esd) that occurred when the technologist interacted with the grounded outlet while unplugging the unit which had not been powered off.The medrad® mrxperion injection system operation manual cautions the user as follows: electric shock hazard - serious patient and/or worker injury or death may result.Turn off any equipment that could generate a high level electrostatic charge.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Event or Problem Description
The customer reported the following: while performing a signal to noise ratio (snr) test on the medrad® mrxperion injection system (serial number (b)(6)), the technologist observed that the snr result was lower than expected.Prior to repeating the test, the employee unplugged the energized power supply from the wall outlet without first powering off the unit and experienced an electrical shock sensation.In accordance with hospital protocol, the employee was evaluated in the emergency room and was subsequently discharged.The site has confirmed that the technologist has since returned to full duty with no further issues reported.

• Brand Name: MRXPERION MR INJECTION SYSTEM
• Common Device Name: MRXPERION MR INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 23975385
• Report Number: 2520313-2026-00001
• Device Sequence Number: 4578616
• Product Code: DXT
• UDI-Device Identifier: 00616258025094
• UDI-Public: (01)00616258025094(11)251029
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 87838420
• Device Catalogue Number: MRXPERION
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown