MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-14 for SPIRIT 3000 DENTAL CHAIR SP30 3003 manufactured by Pelton & Crane.
[26136912]
Upon visual inspection by the authorized (b)(4) distributor, it was identified that the four mounting bolts that attaches the rear cuspidor bracket to the dental chair were loose which caused the top two mounting bolts to break. The distributor has already disposed of the bolts therefore (b)(4) cannot complete the evaluation. The dental chair is over 10 1/2 years old and is past the expected life of the device.
Patient Sequence No: 1, Text Type: N, H10
[26136913]
It was reported that a dental hygienist was performing routine medical treatment to a patient when the rear mounted cuspidor fell off the (b)(4) sp30 dental chair. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2015-00020 |
| MDR Report Key | 5075914 |
| Date Received | 2015-09-14 |
| Date of Report | 2015-08-17 |
| Date of Event | 2015-08-17 |
| Date Mfgr Received | 2015-08-17 |
| Device Manufacturer Date | 2005-02-21 |
| Date Added to Maude | 2015-09-14 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | PELTON & CRANE |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPIRIT 3000 DENTAL CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | NRU |
| Date Received | 2015-09-14 |
| Model Number | SP30 |
| Catalog Number | 3003 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-14 |