MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-22 for CLINITRON TRAPEZE * manufactured by Hill-rom Company, Inc.
[312942]
Overhead trapeze fell onto the bed while nurse was doing dressing change on patient's sacral wound. Patient was turning so did not come into contact with trapeze when it fell. Technical assessment performed by biomed is that trapeze clamp and screw was bent. Will be working with manufacturer and rental company on follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 559056 |
| MDR Report Key | 559056 |
| Date Received | 2004-11-22 |
| Date of Report | 2004-11-22 |
| Date of Event | 2004-11-16 |
| Report Date | 2004-11-22 |
| Date Reported to FDA | 2004-11-22 |
| Date Added to Maude | 2004-12-14 |
| 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 | CLINITRON TRAPEZE |
| Generic Name | TRAPEZE |
| Product Code | ILZ |
| Date Received | 2004-11-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 548753 |
| Manufacturer | HILL-ROM COMPANY, INC |
| Manufacturer Address | 1069 STATE ROAD 46; EAST; MAIL BATESVILLE IN 470069167 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-11-22 |