FDA Adverse Event
Malfunction
Summary report: N
ENTRAK 2500
MDR report key: 2100415
·
Received May 13, 2011
Report
- Report Number
- 1720753-2011-07331
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 13, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REP REPLACED THE TRANSMITTER AND THE RECEIVER AND RESEATED THE CABLE TO THE MOUSE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD LOCK UP DURING BOOT UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTRAK 2500 | RADIOLOGICAL PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ENTRAK 2500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |