MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-08-23 for SKYTRON 3600B manufactured by Mizuho Medical Co., Ltd..
[696384]
Table tilted with patient on it at the hospital.
Patient Sequence No: 1, Text Type: D, B5
[7881212]
Colcom surgical dispatched their certified service technician to the facility to make a determination of the complaint. The technician found a leak in the check valve that controls the tilt function. He also found a torn o-ring in the mini valve assembly. He replaced the o-ring and replaced the check valve. The table has been put back in service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825014-2007-00011 |
| MDR Report Key | 910964 |
| Report Source | 08 |
| Date Received | 2007-08-23 |
| Date of Report | 2007-08-22 |
| Date of Event | 2007-07-25 |
| Date Facility Aware | 2007-07-27 |
| Report Date | 2007-08-22 |
| Date Reported to FDA | 2006-08-22 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2007-10-22 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MRK BLDG. 5F 2-27-17 HONGO, BUNKYO-KU |
| Manufacturer City | TOKYO 113-0033 |
| Manufacturer Country | JA |
| Manufacturer Postal | 113-0033 |
| Manufacturer Phone | 1338181705 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL TABLE |
| Product Code | BWN |
| Date Received | 2007-08-23 |
| Model Number | 3600B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 902089 |
| Manufacturer | MIZUHO MEDICAL CO., LTD. |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-23 |