FDA Adverse Event
Malfunction
Summary report: N
ACCURUS 800CS
MDR report key: 1843355
·
Received September 22, 2010
Report
- Report Number
- 2028159-2010-01796
- Event Type
- Malfunction
- Date Received
- September 22, 2010
- Date of Event
- August 23, 2010
- Report Date
- August 23, 2010
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- PMA / PMN Number
- K911808
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE PROBLEM REPORTED. NO SYSTEM MESSAGE WAS FOUND IN THE EVENT LOG. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
THE NURSE REPORTED THE SYSTEM WENT BLANK AND A SYSTEM MESSAGE DISPLAYED. THE SYSTEM WAS REBOOTED AND THE CASE WAS COMPLETED AS PLANNED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCURUS 800CS | PHACOFRAGMENTATION SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | ACCURUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |