MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-11 for DENTAL EZ ACCS CHAIR AXCS manufactured by Dental Ez.
[2608644]
I purchased two dentalez chairs in 2000. One was dysfunctional from the start. The other would stop working from time to time and i would unplug it and plug it back in to reboot the chair. When hitting return on the more disfunctional chair, it has moved to the fully reclined position on three occasions posing a risk to a pt with a bad back. The chairs have had 25 service calls in the past two years, with all parts being replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025103 |
| MDR Report Key | 2544675 |
| Date Received | 2012-04-11 |
| Date of Report | 2012-04-11 |
| Date Added to Maude | 2012-04-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTAL EZ ACCS CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2012-04-11 |
| Model Number | AXCS |
| Lot Number | NA |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTAL EZ |
| Manufacturer Address | 2-WEST LIBERTY BLVD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-11 |