MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-10-20 for 5319G WILSON FRAME manufactured by Mizuho Osi.
[2273355]
The 5319g wilson frame's base was found broken and the pads and foot pads were also damaged. Our technician also noted that there is a crack in the back side of the base. This product came in as a repair and not a complaint. No pt or healthcare injury is related to this event.
Patient Sequence No: 1, Text Type: D, B5
[9566576]
Failure unk, investigation on-going. No pt or healthcare injury involved in this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2011-00032 |
| MDR Report Key | 2358394 |
| Report Source | 07 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-10-20 |
| Date Mfgr Received | 2011-10-20 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-07-09 |
| 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 94587 |
| Manufacturer Country | US |
| Manufacturer Postal | 94587 |
| Manufacturer Phone | 5104768128 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5319G WILSON FRAME |
| Generic Name | OPERATING ROOM TABLE ACCESSORY |
| Product Code | JEB |
| Date Received | 2011-10-20 |
| Model Number | 5319G |
| Catalog Number | 5319G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO OSI |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 94587 US 94587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-20 |