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 300 IMAGING TABLE 75209-T01 manufactured by Oakworks, Inc.,.
[78186237]
Recurring issue.
Patient Sequence No: 1, Text Type: N, H10
[78186238]
(b)(6) from performance imaging technologies called in and stated that they kick the foot pedal while moving around the table and in some instances, the foot pedal gets kicked under the base of the table. The foot pedal will get lodged under the base and the button engages. This has occurred with patients on the table. The last time this happened, they were getting ready to perform a lumbar injection when the foot pedal was kicked under the base. This engaged the lateral roll movement and the table started to roll. They were able to stop it in time and there was no harm to the patient. When asked if the patient was strapped down using the patient safety strap that comes with the table, the customer said no, they do not use the straps typically due to the location of the injections within the spinal column. (b)(6) was advised to unplug the foot pedal and to discontinue the use of it. They can use the hand control to operate the table.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529571-2017-00005 |
| MDR Report Key | 6660012 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-06 |
| Date of Event | 2015-03-31 |
| Date Mfgr Received | 2015-03-31 |
| Device Manufacturer Date | 2012-12-17 |
| 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 |
| 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 | 75209-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 |