FDA Adverse Event
Other
Summary report: N
*
MDR report key: 1290124
·
Received January 8, 2009
Report
- Report Number
- 3003768277-2009-00002
- Event Type
- Other
- Date Received
- January 8, 2009
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- LNH
- PMA / PMN Number
- k920791
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE CABLES WERE SEPARATED FROM THE PT WITH ONLY A FOLDED BED SHEET. IT MAY HAVE HAPPENED THAT THE SHEET SHIFTED DURING THE EXAMINATION WHICH MAY HAVE RESULTED IN INSUFFICIENT DISTANCE BETWEEN THE COIL CABLE AND THE PT. ALSO, SEVERAL SCANS WITH HIGH SAR LEVELS WERE PERFORMED. THE HEATING WAS MOST LIKELY CAUSED BY UNWANTED RF INTERFERENCE. ALSO, DEPENDING OF THE POSITION OF THE COIL AND THE PT, THIS COULD LEAD TO HEATING OF THE COIL CABLE OR ELEMENTS AND/OR UNWANTED RF INTERFERENCE. THE INSTRUCTIONS FOR USE ALREADY CONTAIN EXTENSIVE WARNINGS TO PREVENT PT HEATING. THE SYSTEM WAS MEETING SPECS. NOTE THE INDICATED IMPORTER HAS REC'D FDA EXEMPTION NUMBER, TO SUBMIT ONE FDA FORM TO SATISFY BOTH THE IMPORTER AND MFR FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | LNH | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |