MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for OAKWORKS MEDICAL CFPM 400 IMAGING TABLE 75204-T01 manufactured by Oakworks Inc..
| Report Number | 2529571-2020-00004 |
| MDR Report Key | 9843260 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-02 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-10-26 |
| Device Manufacturer Date | 2015-08-19 |
| Date Added to Maude | 2020-03-17 |
| 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 | 7172356708 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OAKWORKS MEDICAL CFPM 400 IMAGING TABLE |
| Generic Name | IMAGING TABLE |
| Product Code | IXR |
| Date Received | 2020-03-17 |
| Model Number | CFPM 400 |
| Catalog Number | 75204-T01 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-17 |