FDA Adverse Event
Malfunction
Summary report: N
INSTATRAK 3500
MDR report key: 2031062
·
Received March 4, 2011
Report
- Report Number
- 1720753-2011-01963
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 21, 2011
- Report Date
- March 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- LLZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE BOOTED UP THE SYSTEM AND POWERED ON THE UPS. THE CUSTOMER WAS INSTRUCTED TO LEAVE THE SYSTEM PLUGGED IN TO CHARGE THE BATTERY. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSTATRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | LLZ | GE OEC MEDICAL SYSTEMS (SLC) | INSTATRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |