FDA Adverse Event
Malfunction
Summary report: N
SOVEREIGN COMPACT
MDR report key: 1911284
·
Received November 22, 2010
Report
- Report Number
- 2020664-2010-00126
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- October 26, 2010
- Report Date
- October 26, 2010
- Manufacturer
- ABBOTT MEDICAL OPTICS (AMO)
- Product Code
- HQC
- PMA / PMN Number
- K003638
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PHACOEMULSIFICATION MACHINE WAS EXAMINED AND TESTED BY AN AMO SERVICE TECH AT THE CUSTOMER'S LOCATION. THE TECH INDICATED THE UNIT WOULD NOT START UP AND REPLACED THE MAX DRIVE BOARD. THE TECH NOTED THERE WAS BALANCE SALT SOLUTION INSIDE OF MACHINE WHICH MAY HAVE CONTRIBUTED TO THE EVENT. THE TECH CALIBRATED VACUUM SETTINGS AND THE UNIT PASSED PRIME AND TUNE PROCESS. THE MACHINE OPERATES TO AMO SPECS. NO ADD'L INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CLINIC REPORTED SMOKE COMING OUT OF THE FILTER OF MACHINE AT THE START OF SET UP. THE MACHINE WAS NOT USED FOR ANY PROCEDURE. THE MACHINE WAS TAKEN OUT OF SERVICE UNTIL IT WAS SERVICED BY AN AMO TECH. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOVEREIGN COMPACT | HQC | ABBOTT MEDICAL OPTICS (AMO) | CMP680300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |