MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-03-23 for RITTER 391 ENT CHAIR NA manufactured by Midmark Corp..
[180003]
The pt was in the exam chair which was raised to its highest point. The chair fell all the way to its lowest point, making a loud noise that scared everyone in the office. There were no injuries to the staff or pt. It was reported that the chair would not completely come to a stop once the foot pedal was released and the table made a cracking noise whenever it was raised. This was reported to hosp maintenance three weeks before the incident, but no one showed up to check the table and the doctor continued to use it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523530-2000-00001 |
| MDR Report Key | 271023 |
| Report Source | 07 |
| Date Received | 2000-03-23 |
| Date of Report | 2000-03-20 |
| Date of Event | 2000-02-28 |
| Date Mfgr Received | 2000-02-28 |
| Device Manufacturer Date | 1999-07-01 |
| Date Added to Maude | 2000-03-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MIKE SNYDER |
| Manufacturer Street | 60 VISTA DR |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375268390 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITTER 391 ENT CHAIR |
| Generic Name | MEDICAL EXAM CHAIR |
| Product Code | ETF |
| Date Received | 2000-03-23 |
| Returned To Mfg | 2000-03-16 |
| Model Number | 391 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 262365 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | 60 VISTA DR. VERSAILLES OH 45380 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-03-23 |