MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-09-03 for NUSTAR DENTAL CHAIR DC1700 manufactured by Marus.
[3933884]
A dentist had positioned a pt for treatment in a lowered reclined position when the lift assembly broke on the marus dc1700 dental chair resulting in the seat assembly to fall backwards towards the floor with the pt in the chair. The pt valid out of the back of the chair and onto the floor. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[11263244]
Upon eval 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. Marus contacted the supplier of the front truss assembly to inform them of this issue. The supplier informed marus that they will define areas of work in process (wip) for status identification of the welding process. They will also update fqc document to include a conformity check of weldments to ensure front truss assemblies are manufactured to marus specifications. All front truss assemblies the supplier had in inventory were to marus specifications. Marus also confirmed all front truss assemblies in house from our supplier were to manufacturers specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2013-00015 |
| MDR Report Key | 3376662 |
| Report Source | 08 |
| Date Received | 2013-09-03 |
| Date of Report | 2013-08-07 |
| Date of Event | 2013-08-07 |
| Date Mfgr Received | 2013-08-07 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2013-12-03 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUSTAR DENTAL CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2013-09-03 |
| Returned To Mfg | 2013-08-09 |
| Model Number | DC1700 |
| Catalog Number | DC1700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARUS |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-03 |