FDA Adverse Event
Malfunction
Summary report: N
ITRAK 3500
MDR report key: 2021869
·
Received February 25, 2011
Report
- Report Number
- 1720753-2011-01680
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 28, 2011
- Report Date
- February 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A MFR'S SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CMOS BATTERY WAS REMOVED AND REPLACED. THE CMOS SETTINGS WERE RESET. THE SYSTEM WAS TESTED AND OPERATED AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE CMOS BATTERIES ON THE ITRAK 3500 SYSTEM ARE DEAD. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITRAK 3500 | NONE | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | ITRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |