MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T; INGENIA 1.5T R5 BASED

Model Number 781341

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 07/03/2020

Event Type  malfunction  

Event Description

Philips received a report on a fire in the hospital which damaged the mr system.

Event Description

Philips received a report on a fire in the hospital which damaged the mr system.

• Brand Name: INGENIA 1.5T
• Type of Device: INGENIA 1.5T R5 BASED
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10244162
• MDR Text Key: 198330908
• Report Number: 3003768277-2020-01004
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: 884838055322
• Combination Product (y/n): N
• PMA/PMN Number: K163116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 781341
• Device Catalogue Number: 781341
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/03/2020
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/03/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other