FDA Adverse Event
Other
Summary report: N
CERETOM NL-3000
MDR report key: 2608658
·
Received May 31, 2012
Report
- Report Number
- 3004938766-2012-00001
- Event Type
- Other
- Date Received
- May 31, 2012
- Date of Event
- May 8, 2012
- Report Date
- May 17, 2012
- Manufacturer
- NEUROLOGICA, CORPORATION
- Product Code
- JAK
- PMA / PMN Number
- K051765
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS RESULTED IN THE FSE'S HAND BEING BURNED AND NEEDING MEDICAL INTERVENTION. THE MOBILE CT SCANNER AND ANY OF IT'S ACCOMPANYING ACCESSORIES DID NOT INDUCE THIS INJURY, WHICH IS ULTIMATELY THE RESULT OF THE FSE'S INVOLUNTARY GRIPPING OF THE SOLDERING IRON. THE FSE WAS TREATED WITH A DRESSING AND RETURNED TO WORK.
Description of Event or Problem · 1
DURING ATTEMPTED REPAIR OF A SUBSYSTEM IN OUR MOBILE CT SCANNER, A NEUROLOGICA FIELD SERVICE ENGINEER (FSE) UNINTENTIONALLY GRABBED HOLD OF A LIVE SOLDERING IRON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERETOM NL-3000 | X-RAY COMPUTED TOMOGRAPHY SYSTEM | JAK | NEUROLOGICA, CORPORATION | NL3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |