MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. PHILIPS; SYSTEM, NUCLEAR MAGNETIC RESONANCE

Model Number INGENIA 3.0T

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/12/2018

Event Type  malfunction  

Event Description

The device quenched without any identifiable cause, which took it out of service for a period of weeks.Per manufacturer response to the hospital, the device is being repaired (unsure of the cause).

• Brand Name: PHILIPS
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS, INC.; 5520 nobel dr; fitchburg WI 53711
• MDR Report Key: 8145982
• MDR Text Key: 129754196
• Report Number: 8145982
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2018,12/04/2018

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: No Information
• Device Model Number: INGENIA 3.0T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1