MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA 3.0T CX; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	INGENIA 3.0T CX
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a patient was cut on the edge of the patient support.During horizontal travel of the patient support, the patient's fingers were in the gap between the top and the patient support and were pinched resulting in the cut.The patient was not under anesthesia and the scan was completed.The cut was on the peripheral joint of the left ring finger.Seven sutures were placed to close the injury.The patient is expected to fully recover once the sutures have been removed.
Additional Manufacturer Narrative
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).The patient had been strapped in, but because he was conscious, he was loosely secured in place.In addition, no arm boards (protective measures to prevent finger pinching) were used 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.

• Brand Name: INGENIA 3.0T CX
• 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: 22085954
• Report Number: 3003768277-2025-004773
• Device Sequence Number: 7866476
• Product Code: LNH
• UDI-Device Identifier: 00884838068452
• UDI-Public: 00884838068452
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162931
• 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): 05/27/2025

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 3.0T CX
• Device Catalogue Number: 781271
• 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: 05/20/2025
• Initial Report FDA Received Date: 05/27/2025
• 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: Other; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 53 KG