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

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.

• Brand Name: INTERA 1.5T PULSAR NEW
• 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: 7306222
• MDR Text Key: 101404014
• Report Number: 3003768277-2018-00016
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K052013
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 781295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1433-2018
• Patient Sequence Number: 1