• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS HEALTHCARE ACHIEVA 1.5T NOVA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 781196
Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)
Patient Problems Chest Pain (1776); Dizziness (2194)
Event Date 01/13/2017
Event Type  malfunction  
Manufacturer Narrative
The investigation is still ongoing on this event. When the investigation is completed a follow-up will sent to the fda.
 
Event Description
Philips received a report from a customer related to a magnet quench with an achieva 1. 5t mr system. The magnet quench occurred during an mr examination and filled the mr room half way with helium gas. Both the patient and hospital personal sustained pain on the chest and dizziness afterwards, but no serious injuries were reported.
 
Manufacturer Narrative
The quench was determined to have happened spontaneously. Conditions found at site (e. G. Presence of ice) are known to increase the probability of a magnet quench. The fact that helium gas filled the mr examination room was caused by a combination of factors: - the quench outlet was (partially) blocked by a birds nest - the burst disk o ring may have been cracked or the bolt(s) on the burst disk mounting plate were not tightened enough. The local philips service organization initiated an action to have the helium venting outlet changed to the current requirements as documented in the planning reference data (prd).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACHIEVA 1.5T NOVA
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 Key6272557
MDR Text Key65914285
Report Number3003768277-2017-00003
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K052013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Hospital Service Technician
Type of Report Initial,Followup
Report Date 01/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number781196
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 Received01/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2008
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: 01/24/2017 Patient Sequence Number: 1
-
-