FDA Adverse Event
Malfunction
Summary report: N
INSTA TRAK 3500
MDR report key: 2102441
·
Received May 20, 2011
Report
- Report Number
- 1720753-2011-07510
- Event Type
- Malfunction
- Date Received
- May 20, 2011
- Date of Event
- May 9, 2011
- Report Date
- May 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- IZL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN OVER THE PHONE INVESTIGATION AND INSTRUCTED THE CUSTOMER TO REATTACH THE INSTRUMENT ONTO THE SNAP RECEIVER CABLE. THEY DID THAT AND THEN THE SYS DID RECOGNIZE THE INSTRUMENT ON THE CABLE AND THEY WERE ABLE TO CALIBRATE THE INSTRUMENT. THE SYS WAS FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S STRAIGHT ASPIRATOR COULD NOT BE CALIBRATED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSTA TRAK 3500 | RADIOLOGICAL IMAGE PROCESSING | IZL | GE OEC MEDICAL SYSTEMS (SLC) | INSTA TRAK 3500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |