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 CFLU 401 LITHOTRIPSY/UROLOGY TABLE 75216-T01 manufactured by Oakworks, Inc.,.
[78192213]
Patient Sequence No: 1, Text Type: N, H10
[78192214]
The customer called in a panic because the column had been lowered onto the foot pedal while a patient was on the table. Because the column was on the pedal, they could not operate the table at all. The customer was walked through unplugging the foot pedal so that the hand control would operate. This was successful. There was no harm done the patient. The customer is stating that the foot pedal is operational and no damage was done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529571-2017-00004 |
| MDR Report Key | 6659997 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-05 |
| Date of Event | 2014-11-24 |
| Date Mfgr Received | 2014-11-24 |
| Device Manufacturer Date | 2014-07-21 |
| 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 CFLU 401 LITHOTRIPSY/UROLOGY TABLE |
| Generic Name | IMAGING TABLE (LITHOTRIPSY/UROLOGY TABLE) |
| Product Code | IXR |
| Date Received | 2017-06-22 |
| Model Number | CFLU 401 |
| Catalog Number | 75216-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 |