MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-31 for AMSCO AMSCO/3080 manufactured by Medical Equipment Consultants, Inc..
[1297970]
Patient fell from the table during surgical procedure. Table tilted deep trendelenburg to low position and head of bed 17 inches from the floor. Patient slipped from under thigh security belt onto the floor. Investigation ongoing as to if bed had any malfunction issues. Questioning new padding as more slippery less resistance with sheet and patient on bed. Noted one pad had no velcro on contact side of bed. Diagnosis or reason for use: surgery. Event abated after use stopped or dose reduced? : yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015394 |
| MDR Report Key | 1651064 |
| Date Received | 2010-03-31 |
| Date of Report | 2010-03-31 |
| Date of Event | 2010-03-05 |
| Date Added to Maude | 2010-04-12 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSCO |
| Generic Name | SURGICAL TABLE |
| Product Code | JEB |
| Date Received | 2010-03-31 |
| Model Number | AMSCO/3080 |
| Lot Number | 36051123 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL EQUIPMENT CONSULTANTS, INC. |
| Manufacturer Address | 12 EAGLE DR. MINSTER OH 45865 US 45865 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-31 |