MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-12 for CLEARCHART * manufactured by Reichert, Inc.
[17464744]
The screen keeps going out and occasionally has blotches across it that affects the uniformity of back lighting, which may make eye measurement using this potentially inaccurate. The cabinets are too shallow and the power supply needs to be changed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2841563 |
| MDR Report Key | 2841563 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-12 |
| Date of Event | 2012-09-13 |
| Report Date | 2012-10-12 |
| Date Reported to FDA | 2012-10-12 |
| Date Added to Maude | 2012-11-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARCHART |
| Generic Name | CHART, VISUAL ACUITY |
| Product Code | HOX |
| Date Received | 2012-10-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REICHERT, INC |
| Manufacturer Address | 3362 WALDEN AVE. DEPEW NY 14043 US 14043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-12 |