MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-02-15 for DC1235 DENTAL CHAIR manufactured by Dental Equipment, Llc (dba Newberg Mfg).
[1886412]
The link arm assembly which holds the cuspidor to the dental chair broken allowing the cuspidor to fall to the floor.
Patient Sequence No: 1, Text Type: D, B5
[8995142]
Newberg mfg recently became aware of failures of the link arm assembly that connects some rear mounted options (cuspidors, assistants instrumentation, and hygiene systems) to the dental chair which may potentially break and fall off the dental chair. Outside lab testing determined that the failure was due to hydrogen embrittlement of the link arm bolt. This failure is caused by not properly baking the bolts after they are zinc plated in a timely manner. All bolt failures were from the same lot number. A decision was made by dental equipment llc to conduct a voluntary recall of the affected link arm assemblies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004517290-2011-00004 |
| MDR Report Key | 2040306 |
| Report Source | 08 |
| Date Received | 2011-02-15 |
| Date of Report | 2011-02-24 |
| Date of Event | 2011-02-24 |
| Date Mfgr Received | 2011-02-24 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2012-02-06 |
| 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, MANAGER |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DC1235 DENTAL CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2011-02-15 |
| Model Number | DC1235 |
| Catalog Number | DC1235 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTAL EQUIPMENT, LLC (DBA NEWBERG MFG) |
| Manufacturer Address | 705 SOUTH SPRINGBROOK RD. BLDG C NEWBERG OR 97132 US 97132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-15 |