MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. MR 5300; SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	MR 5300
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.
Event or Problem Description
Philips received a report that the patient sustained a burn to the right upper arm with reddening of the skin and blistering.Additionally, a picture provided shows a blister that appears larger than 2.5 cm, although measurements of the blister were not provided.The patient was provided cooling and topical ointment and is expected to fully recover.
Additional Manufacturer Narrative
After our investigation and analysis, it was concluded that the mr system used in this case was working correctly.There is no indication of a malfunction of the mr system used that could have contributed to the incidents.The injury, 2nd degree burn to the right upper arm with reddening of the skin and blistering, can only be explained by close proximity of the coil cable to the skin.Although it was mentioned that padding was used to prevent this contact, it was also mentioned that the cable and filter of this msk m coil were near to the location of the patient harm (effective distance near to 5cm), and that the patient also moved during the study.The patient didn't alert the technician that he felt heat and he didn't press nurse call.He only commented it to technician when study finished.

• Brand Name: MR 5300
• Common Device Name: SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 21392739
• Report Number: 3003768277-2025-001545
• Device Sequence Number: 20901392
• Product Code: LNH
• UDI-Device Identifier: 00884838099364
• UDI-Public: (01)00884838099364
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K223458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: MR 5300
• Device Catalogue Number: 782110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Unknown
• Patient Weight: 90 KG