MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 3.0T

Model Number	INGENIA 3.0T
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a customer broke a finger when his finger was crushed between the scanner and the trolley.
Additional Manufacturer Narrative
Philips has started an investigation.A follow up/final report will be submitted when the investigation has been completed.
Additional Manufacturer Narrative
The customer stated that there was a slight attractiveness on the 3t mri towards the flextrak and probably the person assisting removing the flextrak at the feet end acted quicker which caused the flextrak to pivot in towards the scanner trapping their finger against the bore.As per requirement specifications, forces acting on the trolley due to magnetic attraction by magnet shall not exceed 60n.The trolley has been tested for the same and the actual force of attraction on the trolley is 0n.Hence the trolley does not move at all due to magnetic attraction.Even if the trolley moves with the force of 60n, it will not cause an injury or fracture to the finger.Conclusion: the incident happened as the person at the foot end of the trolley pulled the trolley out quicker than the person who trapped her hand at the head end, the trolley pivoted against the bore trapping her hand causing the injury.There is a warning given in the ifu to avoid fast movement of the trolley, especially at the corners.There is also a warning sticker for crushing of the hand present on the magnet cover warning against finger pinching.

• Brand Name: INGENIA 3.0T
• Common Device Name: INGENIA 3.0T
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 16590273
• Report Number: 3003768277-2023-01855
• Device Sequence Number: 19541655
• Product Code: LNH
• UDI-Device Identifier: 00884838009813
• UDI-Public: 884838009813
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110151
• 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,Followup

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
• Device Catalogue Number: 781377
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 08/16/2023
• 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
• Patient Age: 59 YR
• Patient Sex: Female