MAUDE Adverse Event Report: PHILIPS HEALTHCARE INGENIA 3.0T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	781342
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/18/2019
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 to be a use error.Device evaluated by mfr: known inherent risk of an mr system.
Event or Problem Description
Assistant doctor moved a magnetic aspirator into rf room.This aspirator was attracted to the mr system.The anesthetist's leg was between the aspirator and the mr system, which resulted in a broken leg.

• Brand Name: INGENIA 3.0T
• 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: 8560262
• Report Number: 3003768277-2019-00034
• Device Sequence Number: 16603466
• Product Code: LNH
• UDI-Device Identifier: 00884838055339
• UDI-Public: (01)00884838055339
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K110151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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: 781342
• 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: 04/24/2019
• Initial Report FDA Received Date: 04/29/2019
• 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: Required Intervention