MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-20 for ALPHASTAR * manufactured by Maquet, Inc..
[15004256]
The head of bed was pushed in prior to patient's arrival in the or room. Upon turning the bed for positioning, a staff member pulled and turned the head of the bed. The head came out of bed and the patient's head hyper-extended and flexed forward. A cervical collar was placed on the patient, and portable x-rays were taken on the patient's neck. This table uses a hand operated crank to lock the head into position. If the handle is not cranked hard enough, the locking mechanisms may not be safely initiated. However, locking/tightening of the head may be difficult for some individuals who are less physically strong. Due to the fact that this is a repeated problem in our facility, other types of beds are being considered for purchase.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 878898 |
| MDR Report Key | 878898 |
| Date Received | 2007-06-20 |
| Date of Report | 2007-06-20 |
| Date of Event | 2007-06-19 |
| Report Date | 2007-06-20 |
| Date Reported to FDA | 2007-06-20 |
| Date Added to Maude | 2007-07-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHASTAR |
| Generic Name | TABLE, SURGICAL |
| Product Code | FSE |
| Date Received | 2007-06-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 858137 |
| Manufacturer | MAQUET, INC. |
| Manufacturer Address | 1140 ROUTE 22 EAST SUITE 202 BRIDGEWATER NJ 08807 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-20 |