MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-08-07 for SKYTRON 6500NB manufactured by Mizuho Medical Co., Ltd.
[16031330]
Table went into trendelenberg when another function button was pressed at: medical center.
Patient Sequence No: 1, Text Type: D, B5
[16115070]
The skytron 6500 table was repaired by the hospital's biomed technician. He found that the cause of the movement was due to an aging spool valve spring. He replaced the spring and placed the table back in service in 2007.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825014-2007-00009 |
| MDR Report Key | 893496 |
| Report Source | 08 |
| Date Received | 2007-08-07 |
| Date of Report | 2007-08-01 |
| Date of Event | 2007-07-26 |
| Date Facility Aware | 2007-07-26 |
| Report Date | 2007-08-01 |
| Date Reported to FDA | 2007-08-01 |
| Device Manufacturer Date | 1994-06-01 |
| Date Added to Maude | 2007-09-27 |
| 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 | 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 1130033 |
| Manufacturer Country | JA |
| Manufacturer Postal | 1130033 |
| Manufacturer Phone | 1338181705 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2007-08-07 |
| Model Number | 6500NB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 13 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 873927 |
| Manufacturer | MIZUHO MEDICAL CO., LTD |
| Manufacturer Address | MRK BLDG 5F 2-27-17 HONGO, BUNYKO-KU TOYKO JA 113-003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-07 |