MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-05-03 for 6850 PROFX OPERATING ROOM TABLE manufactured by Mizuho Osi.
[2148630]
Upon completion of the procedure, it was observed that the spar on the table was releasing from the table. The healthcare worker held the spar as the pt was removed from the table. The spar was then removed from the table and the table was held pending repair.
Patient Sequence No: 1, Text Type: D, B5
[9073653]
The customer provided pictures of the table and the photos show the safety latch has been damaged. This damage caused the latching mechanism to be compromised. Further eval to be completed and f/u will be communicated. (b)(4), 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2011-00014 |
| MDR Report Key | 2104011 |
| Report Source | 05,06,07 |
| Date Received | 2011-05-03 |
| Date of Report | 2011-05-03 |
| Date of Event | 2011-04-26 |
| Date Mfgr Received | 2011-04-26 |
| Date Added to Maude | 2012-03-27 |
| 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 | MIZUHO OSI |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 94587123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 1234 |
| Single Use | 0 |
| Remedial Action | RP |
| 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 | 2011-05-03 |
| Model Number | 6850 |
| Catalog Number | 6850 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO OSI |
| Manufacturer Address | 30031 AHERN AVE. UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-03 |