MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for 6500N manufactured by Skytron, Inc..
[93492954]
Patient Sequence No: 1, Text Type: N, H10
[93492955]
The or table slowly drifted down while the patient was on the table, although the or staff did not select this function. The surgical technician unplugged the unit from the electrical outlet, reinserted plug, and the unit resumed normal operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7074353 |
| MDR Report Key | 7074353 |
| Date Received | 2017-12-01 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-11-01 |
| Report Date | 2017-11-14 |
| Date Reported to FDA | 2017-11-14 |
| Date Reported to Mfgr | 2017-11-14 |
| Date Added to Maude | 2017-12-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TABLE, SURGICAL |
| Product Code | JEB |
| Date Received | 2017-12-01 |
| Model Number | 6500N |
| Device Availability | Y |
| Device Age | 23 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYTRON, INC. |
| Manufacturer Address | 5085 CORPORATE EXCHANGE BLVD SE GRAND RAPIDS MI 49512 US 49512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-01 |