FDA Adverse Event
Injury
Summary report: N
ACHIEVA 1.5T INITIAL SYSTEMS
MDR report key: 2103691
·
Received May 20, 2011
Report
- Report Number
- 3003768277-2011-00385
- Event Type
- Injury
- Date Received
- May 20, 2011
- Date of Event
- April 5, 2011
- Report Date
- May 3, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- LNH
- PMA / PMN Number
- K030520
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- 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 F/U REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE PT WAS SCANNED WITH THE SYNERGY BODY COIL WHICH WAS POSITIONED OVER THE CHEST/LEFT HUMERUS AREA. AFTER THE EXAMINATION A LARGE SECOND DEGREE BURN WAS OBSERVED ON THE RIGHT FOREARM NEAR THE WRIST WHERE THE COIL CABLE WAS ROUTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACHIEVA 1.5T INITIAL SYSTEMS | LNH | PHILIPS HEALTHCARE | 781178 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |