MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-03-03 for MAXSTAR DC1690 DENTAL CHAIR manufactured by Dental Equipment, Llc (dba Newberg Manufacturing).
[1879920]
A distributor was installing a dental chair when the link arm assembly that holds the rear mounted cuspidor broke causing the cuspidor assembly to fall to the floor.
Patient Sequence No: 1, Text Type: D, B5
[9111400]
Newberg manufacturing 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. This complaint was reported to newberg manufacturing on (b)(6) 2011. This event happened during installation and based on information provided at the time, we determined that it was a single incident that was due to an installation error. During our recall investigation, we revisited this case and determined that the bolt on this unit had the same malfunction as the complaints that led to the recall investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004517290-2011-00001 |
| MDR Report Key | 2054075 |
| Report Source | 08 |
| Date Received | 2011-03-03 |
| Date of Report | 2011-01-06 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-01-06 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2011-06-28 |
| 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 DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | DENTAL EQUIPMENT LLC, DBA NEWBERG MANUFACTURING |
| Manufacturer Street | 705 S. SPRINGBROOK RD. BUILDING 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 | MAXSTAR DC1690 DENTAL CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2011-03-03 |
| Model Number | DC1690 |
| Catalog Number | DC1690 |
| 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 MANUFACTURING) |
| Manufacturer Address | 705 S. SPRINGBROOK RD. BUILDING C NEWBERG OR 97132 US 97132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-03 |