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

Model Number	INGENIA AMBITION S
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the results of the analysis, it was determined that the product has not malfunctioned.The root cause of this finger pinching related incident is use error.When placing the patient into the bore, the patient put his left hand on the side of the patient support.As a result, the ring finger of his left hand was broken.The scan was temporarily stopped, and then restarted using the same device.In addition, the patient had not been supported with an arm support or strap (protective measures to prevent finger pinching) at the time of the alleged harm (which, as stated ifu, should have been provided to prevent the patient from grabbing around the table sides and pinching the fingers during horizontal table motion, which is what happened in this event).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.
Event or Problem Description
Philips received a report that the patient was lying on his back, head first and his hand was on the side of the bed and the patient was scheduled to undergo an irm prostate scan.The exam was completed as scheduled.The reported injury occurred at the beginning of the exam, while in process of transferring onto the mri.The patient's finger injury was reported to have occurred on the bed's rail.As per the report provided, the patient got his ring finger stuck in the table rail as it moved to enter the tunnel at the beginning of the examination.The patient status is documented as distal phalanx fracture of the ring finger on the left hand.The photo depicts a simulation of a hand gripping the side of the table, with the index finger gripping the side.The reported injury meets the criteria for serious injury.

• 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: 23754292
• Report Number: 3003768277-2025-015613
• Device Sequence Number: 13102800
• Product Code: LNH
• UDI-Device Identifier: 00884838098343
• UDI-Public: (01)00884838098343
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193215
• 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): 12/09/2025

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: INGENIA AMBITION S
• Device Catalogue Number: 782108
• 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: 11/13/2025
• Initial Report FDA Received Date: 12/09/2025
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 86 KG