MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for HERCULES 6702 manufactured by Skytron Llc.
[173713708]
Patient was positioned in lithotomy in maquet stirrups on the skytron 6702 cysto table, the table suddenly tilted forwards and the patient slowly slid onto the plastic cysto drape, buttocks was on the floor, legs still in stirrups and safety strap remained in place, however the laryngeal mask airway (lma) was dislodged and had to be replaced. The patient was picked up by staff and placed back on table.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9551298 |
| MDR Report Key | 9551298 |
| Date Received | 2020-01-06 |
| Date of Report | 2019-12-26 |
| Date of Event | 2019-12-13 |
| Report Date | 2019-12-26 |
| Date Reported to FDA | 2019-12-26 |
| Date Reported to Mfgr | 2020-01-06 |
| Date Added to Maude | 2020-01-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Brand Name | HERCULES |
| Generic Name | TABLE, OPERATING-ROOM, AC-POWERED |
| Product Code | FQO |
| Date Received | 2020-01-06 |
| Model Number | 6702 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-06 |