MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA 1.5T; SYSTEM NUCLEAR MAGNETIC IMAGING

Model Number	INGENIA 1.5T R5 BASED
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no indication of a malfunction of the mr system (including the nurse call cable/hose) or mr coil used that could have contributed to the incident.The nurse call including the cable could not have contributed to the alleged sustained injury.The nurse call, including the cable (12nc: 989603024152) is designed to not be conductive for heat.The nurse call including the cable do not contain any metal.Accordingly, the investigation of the field service engineer indicated that there was no issue or damage to the nurse call in question.No metal was found inside the nurse call that could have explained the sustained burn.The most likely cause for the observed injury is direct contact between body parts, a so called skin-to-skin contact, in this case between the thumb and the index finger.
Event or Problem Description
Philips received a report that the patient had a burn of approximately 2.5 cm between the thumb and index finger where the call button "hose" was located.

• Brand Name: INGENIA 1.5T
• Common Device Name: SYSTEM NUCLEAR MAGNETIC 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: 20543692
• Report Number: 3003768277-2024-06123
• Device Sequence Number: 7817017
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: 884838055322
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163116
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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: INGENIA 1.5T R5 BASED
• Device Catalogue Number: 781341
• 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: 10/03/2024
• Initial Report FDA Received Date: 10/28/2024
• 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: Other; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 113 KG