MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for ADVANCED CONTROL I-BASE, DC 5803 manufactured by Mizuho Orthopedic Systems, Inc..
[184658471]
Osi table worked prior to procedure, table would rise and lower for pt positioning. During procedure, surgeon asked to moved position of table to lateral position and crna stated that table would not move.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9871566 |
| MDR Report Key | 9871566 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-05 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-24 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | JEA |
| Date Received | 2020-03-24 |
| Model Number | 5803 |
| Catalog Number | 5803 |
| Device Availability | Y |
| 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 | 2020-03-24 |