MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-06-22 for OAKWORKS MEDICAL CFPM 300 IMAGING TABLE 75208-T01 manufactured by Oakworks, Inc.,.
[78191863]
Patient Sequence No: 1, Text Type: N, H10
[78191864]
The end user damaged the foot control. It happened at the end of the day when they were closing up the room. A staff member used the hand control to lower the table not realizing the foot control was under the column and crushed the foot control. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529571-2017-00011 |
| MDR Report Key | 6660073 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-06 |
| Date of Event | 2016-05-11 |
| Date Mfgr Received | 2016-05-11 |
| Device Manufacturer Date | 2015-10-12 |
| 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 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 300 IMAGING TABLE |
| Generic Name | IMAGING TABLE |
| Product Code | IXR |
| Date Received | 2017-06-22 |
| Model Number | CFPM 300 |
| Catalog Number | 75208-T01 |
| 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 |