FDA Adverse Event
Injury
Summary report: N
ACHIEVA 1.5T NEW
MDR report key: 2230732
·
Received August 17, 2011
Report
- Report Number
- 3003768277-2011-00506
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- July 31, 2011
- Report Date
- August 1, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- LNH
- PMA / PMN Number
- K063559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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 PATIENT WAS SCANNED IN A HEAD FIRST SUPINE POSITION WITH THE SPINE 15CH COIL, WHILE A SENSE HEAD COIL WAS ALSO ON THE TABLE, NOT CONNECTED. THE ARM OF THE PATIENT MADE CONTACT WITH THE CABLE OF THE SENSE HEAD COIL DURING SCANNING AND AFTERWARDS A 2ND DEGREE BURN OF APPROXIMATELY 1X3 CM WAS FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACHIEVA 1.5T NEW | LNH | PHILIPS HEALTHCARE | 781296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |