MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-04-27 for AXIS JACKSON TABLE 6977 manufactured by Mizuho Orthopedic Systems, Inc..
[1299229]
During a procedure, a burning smell was noticed. Biomed was called and all requirement was unplugged and sequestered. It was determined that the smell was coming from the surgical table. The pt was examined and no injury was noted. Manufacturer response compressor in unit burned up. Additional info from the user facility: manufacturer response (as per reporter) for surgical table. Device still under warranty "compressor in the modular unit had burnt up".
Patient Sequence No: 1, Text Type: D, B5
[8570955]
Initial review determined the pump inside the controller failed. The pump is being returned to its original manufacturer for eval. Feedback from the supplier is expected. Additional info from the user facility: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2009-00010 |
| MDR Report Key | 1670214 |
| Report Source | 00 |
| Date Received | 2010-04-27 |
| Date of Report | 2009-08-14 |
| Date of Event | 2009-06-25 |
| Report Date | 2009-07-01 |
| Date Reported to FDA | 2009-07-01 |
| Date Mfgr Received | 2009-07-22 |
| Device Manufacturer Date | 2009-03-31 |
| Date Added to Maude | 2011-03-28 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 94587123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94587 1234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIS JACKSON TABLE |
| Generic Name | OPERATING ROOM TABLE TOP |
| Product Code | JEB |
| Date Received | 2010-04-27 |
| Returned To Mfg | 2009-07-28 |
| Model Number | 6977 |
| Catalog Number | 6977 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2010-04-27 |