MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-03 for RITTER 204-001 manufactured by Midmark Corporaton.
[132049714]
Midmark dispatched a certified third party technical service provider for further evaluation of the table. It was determined by the service provider that there was no malfunction of the table or the footstep, and that they were both functioning in combination as intended. After further discussions it was found that the user facility is evaluating their processes for patient entry and exiting of tables.
Patient Sequence No: 1, Text Type: N, H10
[132049715]
After the patient exam, when stepping down from the exam table onto the footstep, the patient slipped while their feet were on the footstool and fell to the ground. The patient was transported to the emergency department for further evaluation. No further information was provided regarding the status of the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523530-2018-00002 |
| MDR Report Key | 8214493 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-03 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-12-05 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2017-11-29 |
| Date Added to Maude | 2019-01-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADAM CLUTTER |
| Manufacturer Street | 60 VISTA DRIVE |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Manufacturer G1 | MIDMARK CORPORATION |
| Manufacturer Street | 60 VISTA DRIVE |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITTER 204-001 |
| Generic Name | MANUAL EXAMINATION TABLE |
| Product Code | FRK |
| Date Received | 2019-01-03 |
| Model Number | 204-001 |
| Catalog Number | 204-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATON |
| Manufacturer Address | 60 VISTA DRIVE VERSAILLES OH 45380 US 45380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-03 |