FDA Adverse Event
Malfunction
Summary report: N
ALLEGRETTO WAVE
MDR report key: 1840064
·
Received September 15, 2010
Report
- Report Number
- 3003288808-2010-00426
- Event Type
- Malfunction
- Date Received
- September 15, 2010
- Report Date
- August 16, 2010
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
ADVERSE EVENT(S): "NONE REPORTED" (NO INFO). PRODUCT PROBLEM(S): "BLANK WAVE CARD" (COMPUTER SOFTWARE ISSUE). A TECHNICIAN REPORTS RECEIVING A BLANK WAVE CARD. WHEN THE WAVE CARD WAS INSERTED INTO THE CARD READER IT READ, "INSERT YOUR CARD; SETUP POSSIBLE WITH SETUP KEY." CURRENT INFO INDICATES THE PROBLEM WITH THE WAVE CARD WAS NOTED PRIOR TO SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEGRETTO WAVE | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |