FDA Adverse Event
Malfunction
Summary report: N
INSTATRAK 3500
MDR report key: 2241364
·
Received August 17, 2011
Report
- Report Number
- 1720753-2011-11024
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- February 19, 2010
- Report Date
- August 17, 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 GE SERVICE CONDUCTED AN ONSITE INVESTIGATION. THE REPRESENTATIVE CLEANED VARIOUS FILES. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. DURING A RETROSPECTIVE REVIEW THIS EVENT WAS DETERMINED TO BE REPORTABLE. IT WAS INCLUDED AS PART OF A RETROSPECTIVE SUMMARY REPORT (RSR) REQUEST TO FDA ON APRIL 26, 2011 (B)(4). FDA REQUESTED THIS EVENT TO BE REMOVED FROM THE RSR REQUEST AND FILED VIA 3500A.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS SLOW TO 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 |