FDA Adverse Event
Malfunction
Summary report: N
FUJI SYNOPSE
MDR report key: 388339
·
Received April 13, 2002
Report
- Report Number
- 2443168-2002-00001
- Event Type
- Malfunction
- Date Received
- April 13, 2002
- Date of Event
- January 9, 2002
- Report Date
- April 11, 2002
- Manufacturer
- FUJIFILM MEDICAL SYSTEM U.S.A., INC.
- Product Code
- LMB
- Removal / Correction Number
- 2443168-04/11/02-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHEN A FACILITY REPRINTED A CT EXAM DEMONSTRATING RIGHT SINUS OCCLUSION ONE MONTH AFTER THE EXAM, A PHYSICIAN NOTICED THE SIDE OF THE OCCLUSION WAS MARKED (INCORRECTLY) AS THE LEFT SIDE. THE FACILITY REPRINTED THE STUDY A SECOND TIME AND THE ORIGINAL CORRECT ORIENTATION APPEARED. THE FACILITY COULD NOT REPRODUCE THE PROBLEM ON FURTHER REPRINTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUJI SYNOPSE | PACS SYSTEM | LMB | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | VERSION 2.0.2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |