MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-17 for 6850 PROFX OPERATING ROOM TABLE manufactured by Mizuho Orthopedic Systems, Inc..
[1958906]
During the use of the table leg spar, the safety lever became disengaged during a case and the spar slipped out of position. The spar was noted by the circulating nurse and surgeon's assistant prior to the case. Discussion with staff members regarding this issue identified this has occurred several times. This was repeated by the clinical engineering staff.
Patient Sequence No: 1, Text Type: D, B5
[9159684]
Unknown failure, will review and advise.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2011-00004 |
| MDR Report Key | 2015849 |
| Report Source | 07 |
| Date Received | 2011-02-17 |
| Date of Report | 2011-02-16 |
| Date of Event | 2011-01-24 |
| Date Mfgr Received | 2011-01-24 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2011-07-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768128 |
| Manufacturer G1 | S.A.A. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6850 PROFX OPERATING ROOM TABLE |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | JEB |
| Date Received | 2011-02-17 |
| Model Number | 6850 |
| Catalog Number | 6850 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-17 |