MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-05-01 for MARUS DENTAL CHAIR DC1320 manufactured by Marus.
[5827469]
A dental professional was performing routine medical treatment to a patient when the swivel weld assembly broke on a marus dental chair causing the upper structure of the chair to fall off the lower section of the chair. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[13322522]
Upon evaluation by the local marus distributor technician, it was identified that the swivel weld assembly broke apart at the weld. The part was not given to the distributor by the doctor therefore ther part was not returned to marus for evaluation. The dental chair is over 13 years old and is past the life of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2015-00006 |
| MDR Report Key | 4745076 |
| Report Source | 08 |
| Date Received | 2015-05-01 |
| Date of Report | 2015-04-03 |
| Date of Event | 2015-04-02 |
| Date Mfgr Received | 2015-04-03 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2015-06-11 |
| 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 | MARUS DENTAL CHAIR |
| Generic Name | DENTAL CHAIR |
| Product Code | EAZ |
| Date Received | 2015-05-01 |
| Model Number | DC1320 |
| Catalog Number | DC1320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-05-01 |