FDA Adverse Event
Injury
Summary report: N
ACHIEVA 1.5T INITIAL SYSTEMS
MDR report key: 1990877
·
Received February 10, 2011
Report
- Report Number
- 3003768277-2011-00117
- Event Type
- Injury
- Date Received
- February 10, 2011
- Date of Event
- January 27, 2011
- Report Date
- January 28, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- LNH
- PMA / PMN Number
- K030520
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): (EVAL: 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 RECEIVED A 2ND DEGREE BURN ON THE SHOULDER WITH A SIZE OF APPROX. 2 CM AFTER EXAMINATION WITH THE SENSE 4 CHANNEL SHOULDER COIL. THE COIL IS REQUESTED BACK FOR INVESTIGATION AND A FOLLOW UP REPORT WILL BE ISSUED IN DUE TIME.
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 | UNKNOWN | Other |