MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-22 for OAKWORKS MEDICAL CFPM 401 IMAGING TABLE 75206-T01 manufactured by Oakworks, Inc.,.
[78451962]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[78451963]
The complaint was received by oakworks, inc. , by a customer in (b)(6). The physician had visited an oakworks, inc. , booth at a trade show. He explained that he had trialed a cfpm 401 imaging table and wanted to provide feedback. There was no patient involvement and no procedure. He merely showed the oakworks, inc. Representative on the table in the booth at the trade show that the food pedal can slip under the table, causing one of the power motions to be activated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529571-2017-00001 |
| MDR Report Key | 6659962 |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-05 |
| Date of Event | 2014-08-14 |
| Date Mfgr Received | 2014-08-14 |
| Date Added to Maude | 2017-06-22 |
| 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. STEPHEN MCKINLEY |
| Manufacturer Street | 923 EAST WELLSPRING RD |
| Manufacturer City | NEW FREEDOM PA 17349 |
| Manufacturer Country | US |
| Manufacturer Postal | 17349 |
| Manufacturer Phone | 7177593087 |
| Manufacturer G1 | OAKWORKS, INC., |
| Manufacturer Street | 923 EAST WELLSPRING RD |
| Manufacturer City | NEW FREEDOM PA 17349 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17349 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OAKWORKS MEDICAL CFPM 401 IMAGING TABLE |
| Generic Name | IMAGING TABLE |
| Product Code | IXR |
| Date Received | 2017-06-22 |
| Model Number | CFPM 401 |
| Catalog Number | 75206-T01 |
| Lot Number | NOT LISTED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OAKWORKS, INC., |
| Manufacturer Address | 923 EAST WELLSPRING RD NEW FREEDOM PA 17349 US 17349 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-22 |