FDA Adverse Event
Injury
Summary report: N
ACS-NT
MDR report key: 2191011
·
Received July 29, 2011
Report
- Report Number
- 3003768277-2011-00474
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- July 20, 2011
- Report Date
- July 22, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- LNH
- PMA / PMN Number
- K945945
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (METHOD, RESULTS, CONCLUSIONS): THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED. A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE PT WAS SCANNED IN A HEAD FIRST/DORSAL POSITION WITH THE SENSE BODY COIL. AFTER THE EXAMINATION, THIRD DEGREE BURNS WERE FOUND ON THE LEFT UPPER ARM AND THIGHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACS-NT | LNH | PHILIPS HEALTHCARE | 78107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |