FDA Adverse Event
Malfunction
Summary report: N
INSTATRAK 3500
MDR report key: 2241339
·
Received August 17, 2011
Report
- Report Number
- 1720753-2011-12098
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- May 10, 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, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE EVALUATION. AFTER TESTING IT IS BELIEVED THAT THE PROBLEM IS WITH THE USB COUPLER IN BACK PANEL OF CART. THE CUSTOMER WILL ORDER AND REPLACE USB COUPLER AND DOUBLE CHECK INTEGRITY OF BOTH UPS AND IT'S BATTERIES. NO FURTHER INFORMATION IS AVAILABLE. 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 MONITOR POWER LIGHT WAS AMBER AND NOT GREEN AS EXPECTED. NO TEXT OR GRAPHICS CAME UP ON MONITOR SCREEN. NO PATIENT INJURY 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 |