MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-28 for DENTAL OPERATING CHAIR E3000 manufactured by Star Dental Products, Inc..
[25784]
The foot control units on the dental chair are extremely fragile and subject to damage easily. The types of damage include broken buttons, switches, cracked cases and connecting cords pulling out of the strain relief. The unusually high level of occurrences has at times rendered as many as 25% of the units in one clinic unusable. The amount of time to obtain replacement warranty parts from the mfr in most cases has exceeded 30 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001378 |
| MDR Report Key | 33823 |
| Date Received | 1996-06-28 |
| Date of Report | 1995-08-31 |
| Date Added to Maude | 1996-07-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTAL OPERATING CHAIR |
| Generic Name | DENTAL OPERATING CHAIR |
| Product Code | KLC |
| Date Received | 1996-06-28 |
| Catalog Number | E3000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35173 |
| Manufacturer | STAR DENTAL PRODUCTS, INC. |
| Manufacturer Address | 1816 COLONIAL VILLAGE LA LANCASTER PA 17601 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-06-28 |