INGENIA
Report
- Report Number
- 3003768277-2025-010215
- Event Type
- Malfunction
- Date Received
- September 17, 2025
- Date of Event
- August 22, 2025
- Report Date
- November 28, 2025
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- LNH
- UDI-DI
- 00884838098336
- PMA / PMN Number
- K193215
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
24-SEPT-2025 (B)(6) (COMPLAINT HANDLING AND VIGILANCE REPORTING SPECIALIST) INITIAL EMDR REPORT FOR THE SAME ISSUE, SAME SYSTEM, SAME SRN AND SAME EVENT DATE IS SUBMITTED WITH (B)(6). THE FOLLOW UP REPORT WILL BE SUPPORTED UNDER (B)(6).
INITIAL EMDR REPORT FOR THE SAME ISSUE, SAME SYSTEM, SAME SRN AND SAME EVENT DATE IS SUBMITTED WITH MFR REPORT NUMBER: 3003768277-2025-010431. THE FOLLOW UP REPORT SUBMITTED ON 28-NOV-2025, UNDER MFR REPORT NUMBER: 3003768277-2025-010431 (FOLLOW UP: # 001).
PHILIPS RECEIVED A REPORT ABOUT BURN MARKS ON AXIS Z OF GRADIENT COIL. DURING SCAN, AN USER MESSAGE DISPLAYED SMOKE DETECTOR ALARM. UPON OPENING THE REAR COVER, A VISUAL INSPECTION REVEALED BURN MARKS ON THE AXIS Z BUSBAR CONNECTED TO THE GRADIENT COIL. NO HARM WAS REPORTED RELATED TO THIS INCIDENT. BASED ON THIS EVIDENCE IT WAS DECIDED TO REPORT THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2599687 | INGENIA | FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET | LNH | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | INGENIA ELITION X | 00884838098336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |