MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	SMARTPATH TO DSTREAM FOR 3.0T
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported the fracture was of the middle finger of the left hand.It is reported the patient sustained multiple fractures.The day after the incident, the patient was evaluated and treated in the clinic.The patient is expected to fully recover and there is no photo of the patient's hand.Based on the clinical assessment output, the reported event meets criteria for serious injury.Based on the results of the analysis, it was determined that the product has not malfunction and the cause of the reported incident was a user error.The patient's middle finger was pinched during vertical movement of the patient support connecting the tabletop.The video explaining how this incident occurred (reproduced without the patient or user) was shared, showing that while preparing (positioning) the patient before the scanning, the patient got their hand stuck between the patient support and the table top, during vertical movement of the patient support.The root cause of this finger pinching related incident is use error.The user has not strictly followed the safety instructions and warnings to protect the patient.The finger pinching related incident could have occurred due to misuse by a person who was either untrained and unsupervised (violation of the instructions for use (ifu) and local safety procedures), or by a trained employee who was not following the ifu and/or was also ignoring the warning labels (conscious decision to act in opposition to training and/or normal use instructions).This is considered an unfortunate incident that could have been prevented.The instructions for use clearly mentions this type of hazard and how to prevent it from happening.See the respective section from the instructions for use (ifu): warning fingers, hands, or other extremities of the patient get stuck or hit.Risk of serious patient injury.¿ watch patient extremities during transfer onto the tabletop.¿ make sure that patient extremities remain on the tabletop during transportation and docking to the patient support.¿ use the arm supports or fixate the patient and extremities if necessary (for example for sedated patients).About positioning in general: use the arm supports to prevent the patient from grabbing around the table sides and pinching the fingers during horizontal table motion.
Event or Problem Description
Philips received a report that a patient was injured and that the fracture was of the middle finger.The day after the incident, the patient was evaluated and treated in the clinic.The patient is expected to fully recover and there is no photo of the patient's hand.However, there is a video available explaining how the injury occurred.

• Brand Name: INGENIA
• Common Device Name: FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET
• 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: 22838523
• Report Number: 3003768277-2025-007542
• Device Sequence Number: 9410166
• Product Code: LNH
• UDI-Device Identifier: 00884838095083
• UDI-Public: 00884838095083
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K043147
• 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
• Report Date (Section B): 08/19/2025

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: SMARTPATH TO DSTREAM FOR 3.0T
• Device Catalogue Number: 781270
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/19/2025
• 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 Sex: Unknown