MAUDE Adverse Event Report: PHILIPS HEALTHCARE INGENIA ELITION X; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	781358
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the provided information there is no indication of a malfunction of the mri system.This event is considered a use error.
Event or Problem Description
Philips received a report that a non-compatible mr wheelchair was brought in the examination room.The wheelchair was attracted to the magnet, and the attending nurse got a cut at the eyebrow, requiring stitches.

• Brand Name: INGENIA ELITION X
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 9196393
• Report Number: 3003768277-2019-00081
• Device Sequence Number: 19609767
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• UDI-Public: (01)00884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: 781358
• Device Catalogue Number: 781358
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other