MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS; COIL, MAGNETIC RESONANCE, SPECIALTY

Model Number	SENTINELLE SMS 16CH BREAST 1.5T
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	03/22/2026
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.This incident has also already been reported to you via the distributor siemens under number 3002808157-2026-0000.
Event or Problem Description
Philips received a report about a potential heating incident during a breast examination whilst using the 16 channel breast coil.It was reported the patient complained of a burn on the underside of both breasts.No other clinical or medical information was provided.

• Brand Name: PHILIPS
• Common Device Name: COIL, MAGNETIC RESONANCE, SPECIALTY
• 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: luis casillas lc ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 25040527
• Report Number: 1056069-2026-000001
• Device Sequence Number: 13206838
• Product Code: MOS
• UDI-Device Identifier: 00884838081598
• UDI-Public: 00884838081598
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: SENTINELLE SMS 16CH BREAST 1.5T
• Device Catalogue Number: 989603213622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 07/09/2026
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 77 KG