FDA Adverse Event
Malfunction
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 2160969
·
Received June 16, 2011
Report
- Report Number
- 3003288808-2011-00168
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- December 30, 2009
- Report Date
- December 30, 2009
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IZ
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DURING THE ONSITE INVESTIGATION, THE SERVICE TECH INSTALLED AN UPGRADE TO THE BED CONTROLLER. ROOT CAUSE WAS DETERMINED TO BE A NEED FOR BED CONTROLLER UPGRADE. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTS THE BED MOVED AUTONOMOUSLY WITHOUT USER INTERVENTION. NO PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEGRETTO WAVE EYE-Q | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990631 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |