MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-12-19 for SPIRIT 1700 DENTAL CHAIR SP17 E1704 manufactured by Pelton & Crane.
[5237590]
A dental professional was reclining a patient for treatment in a pelton & crane sp17 dental chair when the lift assembly broke resulting in the seat assembly to fall backwards towards the floor. The patient did not fall out of the chair. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[12678952]
Upon evaluation it was identified that the two welded support block on the front truss assembly had failed as a result of improper welding from our supplier as it was not welded to manufacturers specifications. Pelton & crane has already contacted the supplier of the front truss assembly and informed then of this issue. The supplier informed pelton & crane that they will update fqc document to include a conformity check of weldments to ensure front truss assemblies are manufactured to pelton & crane specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2014-00016 |
| MDR Report Key | 4360995 |
| Report Source | 08 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-12-04 |
| Date of Event | 2014-12-03 |
| Date Mfgr Received | 2014-12-04 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2015-01-07 |
| 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 |
| Manufacturer Street | 11727 FRUEHAUF DR. |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIRIT 1700 DENTAL CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2014-12-19 |
| Returned To Mfg | 2014-12-15 |
| Model Number | SP17 |
| Catalog Number | E1704 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-19 |