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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE INTERA 1.5T PULSAR NEW SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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PHILIPS HEALTHCARE INTERA 1.5T PULSAR NEW SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 781295
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still ongoing on this event. When the investigation is completed a follow-up will be sent to the fda.
 
Event Description
Philips received a report from a customer related to a magnet quench. During the magnet quench the mri examination room was filled with helium via the helium fill port. The helium fill port cap came off at the time of the quench. No persons were injured.
 
Manufacturer Narrative
The reported issue was investigated and it was observed that the 3" metal burst disk did not rupture during the magnet quench. The cause of the reported problem at customer site is due to a malfunction of the 3" metal burst disk; it failed to rupture at the specified pressure as result of a production issue. Actions were initiated to further investigate this problem in detail and a correction for the installed base was initiated by means of a mandatory action. This action include to check all mr sites that possibly may have a 3" metal burst on site or installed on the magnet and replace it with a graphite burst disk. The action in the field exists of 2 parts: inspection of all suspected sites for the presence of the metal burst disk and replacement of the spare metal burst on site if available. Replacement of all affected metal burst disks installed on the mr magnets by a dedicated team.
 
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Brand NameINTERA 1.5T PULSAR NEW
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 Key7306222
MDR Text Key101404014
Report Number3003768277-2018-00016
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K052013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Service Personnel
Type of Report Initial,Followup
Report Date 11/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number781295
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-1433-2018

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