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

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).

• Brand Name: ACHIEVA 1.5T NOVA
• 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
• 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 Key: 6272557
• MDR Text Key: 65914285
• Report Number: 3003768277-2017-00003
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K052013
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 781196
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 80