MAUDE Adverse Event Report: PHILIPS HEALTHCARE INGENIA 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 781341

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Head Injury (1879)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

This event was due to not following mri safety standards by bringing a magnetic tape cutter into the mr examination room.It is known that magnetic materials should not be brought into the examination room.The safety directions as presented in the instruction for use already contain warnings on this matter.

Event Description

Philips received a report on an attraction of a tape cutter to an mr system.The attraction of the tape cutter caused a head injury of 15 centimeter to the patient, which required sutures.

Manufacturer Narrative

Patient demographics (age, sex, weight) added.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INGENIA 1.5T
• Type of Device: 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: 8385958
• MDR Text Key: 137672190
• Report Number: 3003768277-2019-00017
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K110151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 781341
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 58