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U.S. Department of Health and Human Services

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

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PHILIPS HEALTHCARE INGENIA 1.5T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Electromagnetic Compatibility Problem (2927)
Patient Problem Head Injury (1879)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative
This event was due to not following mri safety standards by bringing a walker with magnetic material 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 that a person was injured. A 'patient walker' was attracted to the magnet and hit the technician. The technician was hit by the walker on the forehead and the injury required stitches.
 
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Brand NameINGENIA 1.5T
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
p.o. box 10.000
best 5680 DA
NL 5680 DA
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
veenpluis 4-6
p.o. box 10.000
best 5680 -DA
NL   5680 DA
MDR Report Key7493658
MDR Text Key107562993
Report Number3003768277-2018-00035
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/08/2018 Patient Sequence Number: 1
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