MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-22 for OAKWORKS MEDICAL CFPM 400 IMAGING TABLE 75204-T01 manufactured by Oakworks, Inc.,.
[78192448]
Patient Sequence No: 1, Text Type: N, H10
[78192449]
The customer lowered the column onto the foot pedal and damaged the foot pedal. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529571-2017-00009 |
| MDR Report Key | 6660021 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-06 |
| Date of Event | 2015-10-29 |
| Date Mfgr Received | 2015-10-29 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | BIOMEDICAL ENGINEER |
| 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 |