MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 3.0T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA 3.0T
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that a user accidentally dropped the top part of the nvc head coil onto the patients face during removal of the coil.The patient sustained a broken nose as a result of the drop.
Additional Manufacturer Narrative
Philips has investigated the incident.There was no malfunction of the coil that was used.The top part of the coil slipped from the hand of the user during removal which caused the fall.This is considered an unfortunate incident that could have been prevented.No further actions are required.

• Brand Name: INGENIA 3.0T
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• 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: 17150090
• Report Number: 3003768277-2023-03700
• Device Sequence Number: 3930576
• Product Code: LNH
• UDI-Device Identifier: 00884838009813
• UDI-Public: 884838009813
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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: 06/12/2023
• Initial Report FDA Received Date: 06/19/2023
• 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: 74 YR
• Patient Sex: Female