FDA Adverse Event
Injury
Summary report: N
LEGACY DIGITAL
MDR report key: 3634800
·
Received January 29, 2014
Report
- Report Number
- 2126677-2014-00001
- Event Type
- Injury
- Date Received
- January 29, 2014
- Date of Event
- December 30, 2013
- Report Date
- December 30, 2013
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- IXR
- PMA / PMN Number
- K973039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
GE HEALTHCARE'S FIELD ENGINEER NAME WAS NOT PROVIDED. GE HEALTHCARE'S FIELD ENGINEER INFORMATION WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE GE HEALTHCARE FIELD SERVICE ENGINEER WAS REPLACING A HIGH VOLTAGE TRANSFORMER CABLE OF A LEGACY SYSTEM, THE EMPLOYEE'S FINGER WAS CAUGHT BETWEEN THE X-RAY TUBE AND THE TOP BASE OF THE TABLE. AS A RESULT, THE FIELD SERVICE ENGINEER'S DISTAL LEFT MIDDLE FINGER WAS AMPUTATED ROUGHLY ONE THIRD THE WAY DOWN THE FINGERNAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64502 | LEGACY DIGITAL | TABLE, RADIOGRAPHIC, TILTING | IXR | GE MEDICAL SYSTEMS, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |