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

Model Number 781343

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 about a fire incident in the technical room of an achieva 1.5t.No injuries occurred.

Manufacturer Narrative

The fire started at the ups and there was no malfunction of the mr system.It was concluded that the city could not provide reliable mains power according to philips' specification.The lack of reliable mains power has the following consequences: high power and repetitive extended energy draw on ups energy storage (batteries) without proper recovery time for the same energy storage.Unreliable air-cooling.The local service personnel (non philips) made their own local repairs on the sealed ups batteries instead of ordering new batteries from ups supplier.The ups manufacturer does not allow such repairs.The above factors resulted in ups battery failure and consequent overheating and short-circuiting in the batteries.

• Brand Name: ACHIEVA 1.5T
• 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: 8145908
• MDR Text Key: 129890073
• Report Number: 3003768277-2018-00093
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: ET
• PMA/PMN Number: K063559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 781343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• 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