MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-28 for SKYTRON HERCULES 6500HD 6500 HD manufactured by Skytron.
[3529330]
During surgical procedure, head of bed broke causing pt's neck to be hyperextended. F/u x-rays were negative. Neuro consult was done and pt was kept overnight for observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030364 |
| MDR Report Key | 3144871 |
| Date Received | 2013-05-28 |
| Date Added to Maude | 2013-06-05 |
| 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 | SKYTRON HERCULES 6500HD |
| Generic Name | SURGICAL TABLE |
| Product Code | LGX |
| Date Received | 2013-05-28 |
| Model Number | 6500 HD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYTRON |
| Manufacturer Address | 5085 CORPORATE EXCAHNGE BLVD S.E. GRAND RAPIDS MI 49512 US 49512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-28 |