FDA Adverse Event
Other
Summary report: N
OLYMPUS AU640
MDR report key: 977849
·
Received January 9, 2008
Report
- Report Number
- 8010047-2008-00006
- Event Type
- Other
- Date Received
- January 9, 2008
- Date of Event
- December 10, 2007
- Report Date
- January 9, 2008
- Manufacturer
- OLYMPUS CORPORATION
- Product Code
- JJE
- PMA / PMN Number
- K961274
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE EVENT IS UNDER INVESTIGATION. THE PART ASSOCIATED WITH THIS EVENT WAS RECEIVED BY OLYMPUS AMERICA INC. ON JAN. 8, 2008 AND FORWARDED TO MANUFACTURER ON JAN. 8, 2008. THE GAS SPRING ON COVER WAS REPLACED IN 2007 AND IS PERFORMING AS EXPECTED. IF REQUIRED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
AN ACCOUNT REPORTED THAT WHILE PERFORMING MAINTENANCE ON THE ANALYZER, THE LID OF THE ANALYZER FELL ON HAND, CAUSING INJURY. EMERGENCY ROOM TREATMENT (X-RAY) DETERMINED HAND WAS NOT BROKEN BUT NEEDED SPLINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS AU640 | AUTOMATED CLINICAL CHEMISTRY ANALYZER | JJE | OLYMPUS CORPORATION | AU640 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |