MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-06-02 for NUSTAR HYDRAULIC CHAIR DC 1700 DC1700 manufactured by Dental Equipment, Llc (dba Newberg Mfg).
[2116189]
A dr office allegedly claimed they saw fire coming out of the side of the dental chair when the chair is activated.
Patient Sequence No: 1, Text Type: D, B5
[9168445]
During the eval of the dental chair by an authorized svc tech it was observed that someone had installed an after market monitor on the chair and had routed the monitor power cable through the inside of the dental chair after the chair had been installed. The spring mechanism inside the seat area of the chair had rubbed through the outer insulation of the power cord which resulted in sparks being emitted from the chair every time the spring assembly rubbed against the monitor power cable. There was no evidence of fire during the eval of the dental chair as there as no smoke damage, soot, or fire damage inside or outside the dental chair. Upon further investigation it was discovered that an unauthorized it svc tech had installed the after market monitor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004517290-2011-00006 |
| MDR Report Key | 2145311 |
| Report Source | 08 |
| Date Received | 2011-06-02 |
| Date of Report | 2011-05-03 |
| Date of Event | 2011-05-03 |
| Date Mfgr Received | 2011-05-03 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2011-07-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK RAY, MGR. |
| Manufacturer Street | 11727 FRUEHAUF DR |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | DENTAL EQUIPMENT, LLC DBA NEWBERG MFG |
| Manufacturer Street | 705 S. SPRINGBROOK RD. BLDG C |
| Manufacturer City | NEWBERG OR 97132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUSTAR HYDRAULIC CHAIR DC 1700 |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2011-06-02 |
| Model Number | DC1700 |
| Catalog Number | DC1700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTAL EQUIPMENT, LLC (DBA NEWBERG MFG) |
| Manufacturer Address | 705 S. SPRINGBROOK RD. BLDG C NEWBERG OR 97132 US 97132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-02 |