MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-03 for OFFEST DOUBLE CLAMP 00-1238-004-00 manufactured by Zimmer Orthopaedic Surgical Products.
[829302]
The patient was on her bed being transported to the or. As the transporter was pushing the bed into the hall, the bed went over a bump in the floor where carpet met hard flooring. The trapeze bolt hanging above the patient sheared off and the triangular part of the trapeze fell on the patient's head. The trapeze is an ortho device attached to an overhead bar at the head of the bed. This triangular bar fell on the patient's head. It was described as a 'knot' on the patient's head and ice was applied. There were no deficits noted. The patient proceeded to the or, completed the surgery satisfactorily. It appears that the manufacturer has made a design change at some point but the part number has remained the same. The part reported in this event is from the old design. In the new design the bolt appears to be thicker and wider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1016489 |
| MDR Report Key | 1016489 |
| Date Received | 2008-03-03 |
| Date of Report | 2008-03-03 |
| Date of Event | 2008-02-28 |
| Report Date | 2008-03-03 |
| Date Reported to FDA | 2008-03-03 |
| Date Added to Maude | 2008-03-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | OFFEST DOUBLE CLAMP |
| Generic Name | TRAPEZE, HOSPITAL BED |
| Product Code | ILZ |
| Date Received | 2008-03-03 |
| Model Number | 00-1238-004-00 |
| Catalog Number | 00-1238-004-00 |
| Lot Number | * |
| ID Number | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 984014 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-03 |