MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-10 for * 5892 manufactured by Mizuho Orthopedic Systems, Inc.
[5285748]
In the or, the sedated patient was moved from a supine position on a gurney to a osi orhtopedic table in prone position. Approximately 30 seconds after being placed on the table the front left wheel fell off and one side of the table dropped to the ground (approximately 4 inches). This sudden drop caused the table to tilt while the patient was on it. Staff quickly grabbed the table and held it in place, protecting the patient, until a gurney was brought in to transfer the patient. There was no harm to the patient and another orthopedic table was brought in and surgery was successfully completed. Biomed inspection of the broken wheel revealed the stem in the caster (wheel) had sustained damage at some time causing the flange that securely holds the stem to the wheel to break off. Unfortunately this area is not an inspection point during pm. Prior to the wheel falling off the table was moving without any wobbling or difficulty. ======================manufacturer response for osi orthopedic table, (brand not provided) (per site reporter). ======================they will inspect the table.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4371782 |
| MDR Report Key | 4371782 |
| Date Received | 2014-12-10 |
| Date of Report | 2014-12-10 |
| Date of Event | 2014-12-05 |
| Report Date | 2014-12-10 |
| Date Reported to FDA | 2014-12-10 |
| Date Reported to Mfgr | 2014-12-30 |
| Date Added to Maude | 2014-12-30 |
| 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 | 3 |
| 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 | * |
| Generic Name | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED |
| Product Code | JEB |
| Date Received | 2014-12-10 |
| Model Number | 5892 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC |
| Manufacturer Address | 30031 AHERN AVE UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-10 |