FDA Adverse Event
Malfunction
Summary report: N
INFINITI VISION SYSTEM
MDR report key: 714520
·
Received May 12, 2006
Report
- Report Number
- 2028159-2006-00155
- Event Type
- Malfunction
- Date Received
- May 12, 2006
- Date of Event
- February 2, 2006
- Report Date
- April 12, 2006
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A FUSE SHORT-CIRCUITED, WITH BURNT ODOR, AFTER A SMALL QUANTITY OF FLUID REN ALONG FUSES WHEN NURSE REMOVED IRRIGATION LINE FROM SOLUTION BOTTLE, WHILE REPLACING DEFECTIVE CASSETTE WITH A FUNCTIONAL ONE DURING TESTING. PROCEDURE BEGAN (RHEXIS) WHILE NURSE WAS STILL TESTING SYSTEM. THERE WAS A FORTY-FIVE MIN DELAY WHILE FUSES WERE REPLACED AND MACHINE RESTARTED. CHANGED PROCEDURE TO AN ECCE. SURGERY WAS UNEVENTFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITI VISION SYSTEM | OPHTHALMIC SURGERY SYSTEM | HQC | ALCON - IRVINE TECHNOLOGY CENTER | INFINITI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |