MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-25 for 6500 ELITE manufactured by Skytron, Llc.
[58275380]
Patient Sequence No: 1, Text Type: N, H10
[58275381]
Two buttons on the operating room table didn't work for reflex positioning for knee case. Optimal position not reached. This is an old device no longer supported by manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6053619 |
| MDR Report Key | 6053619 |
| Date Received | 2016-10-25 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-04-29 |
| Report Date | 2016-09-30 |
| Date Reported to FDA | 2016-09-30 |
| Date Reported to Mfgr | 2016-09-30 |
| Date Added to Maude | 2016-10-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Brand Name | 6500 ELITE |
| Generic Name | TABLE, SURGICAL |
| Product Code | JEB |
| Date Received | 2016-10-25 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYTRON, LLC |
| Manufacturer Address | 5085 CORPORATE EXCHANGE BLVD. SE. GRAND RAPIDS MI 49512 US 49512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-25 |