MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-22 for OAKWORKS MEDICAL CFPM 400 IMAGING TABLE 75201-T01 manufactured by Oakworks, Inc.,.
[78190101]
Per the investigation notes, the quality inspector found marks on the foot control consistent with damage resulting from the foot control being crushed underneath of the column.
Patient Sequence No: 1, Text Type: N, H10
[78190102]
The foot pedal is not operating properly and it will start moving the table on its own. The button appears to be stuck. This has happened during procedures, but has not caused any adverse events. The customer has unplugged the foot pedal and is using just the hand control to operate the table.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529571-2017-00002 |
| MDR Report Key | 6659989 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-05 |
| Date of Event | 2014-08-19 |
| Date Mfgr Received | 2014-08-19 |
| Device Manufacturer Date | 2013-08-16 |
| 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 400 IMAGING TABLE |
| Generic Name | IMAGING TABLE |
| Product Code | IXR |
| Date Received | 2017-06-22 |
| Model Number | CFPM 400 |
| Catalog Number | 75201-T01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 |