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 75204-T01 manufactured by Oakworks, Inc.,.
[78192329]
Recurring issue.
Patient Sequence No: 1, Text Type: N, H10
[78192330]
The end user clinic is having problems with the foot control. When they walk around the table, they are kicking the foot control up under the lower frame and the up function is engaging with the patient on the table. The nurses are aware that this can and does happen. They were advised to unplug the foot pedal and use only the hand control. The customer stated that no patient harm had occurred as they were aware of what caused the movement of the table and were able to react quickly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529571-2017-00006 |
| MDR Report Key | 6660011 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-06 |
| Date of Event | 2015-03-18 |
| Date Mfgr Received | 2015-03-18 |
| Device Manufacturer Date | 2013-09-10 |
| 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 | 75204-T01 |
| 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 | 2017-06-22 |