MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for ADVANCED CONTROL I-BASE, DC 5803 manufactured by Mizuho Orthopedic Systems, Inc..
[144278195]
The bed disengaged while patient was still on the bed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8586190 |
| MDR Report Key | 8586190 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-04-03 |
| Report Date | 2019-04-08 |
| Date Reported to FDA | 2019-04-08 |
| Date Reported to Mfgr | 2019-05-07 |
| Date Added to Maude | 2019-05-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED CONTROL I-BASE, DC |
| Generic Name | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED |
| Product Code | JEB |
| Date Received | 2019-05-07 |
| Model Number | 5803 |
| Catalog Number | 5803 |
| Device Availability | Y |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-07 |