MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for PELTON/MARUS OF THE KAVO KERR DENTAL CHAIR DC1702 manufactured by Kavo Dental Technologies Llc.
[178756474]
I am a service technician dispatched to diagnose a dental chair issue. It was reported a patient fell out of the dental chair. I found the marus chair model dc1702, sn (b)(4) with a manufacturer date of 02/2011 had a catastrophic structural failure causing it to drop the patient. Fda safety report id # (b)(4). Fda received date: 02/07/2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092884 |
| MDR Report Key | 9693603 |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-06 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PELTON/MARUS OF THE KAVO KERR DENTAL CHAIR |
| Generic Name | CHAIR, DENTAL, WITHOUT OPERATIVE UNIT |
| Product Code | NRU |
| Date Received | 2020-02-10 |
| Model Number | DC1702 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL TECHNOLOGIES LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |