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 3600B manufactured by The Kmw Group, Skytron Division.
[18610918]
Pt was on a skytron 3600b table when it started to smell like smoke. The pt was anesthetized and was moved to another table.
Patient Sequence No: 1, Text Type: D, B5
[18725912]
The table was examined in 2007. Upon inspection, it was immediately noticeable that there was damage to the low voltage (24 volt) circuit conductors. These conductors can be found near the electrical connector that plugs into the tables relay box assembly. The exterior insulation of the conductors exhibited signs of damage from heat (slightly melted). Additional investigation revealed that the cause of the failure was a short to ground. It is apparent on the red (+24 volt) conductor that it was pinched against a metal bracket creating a resistant point. This is evident because the imprint of the metal bracket is shaped into the outer jacket of the conductor. Damage to the relay box control circuit resulted from the short which made the table inoperable. It appears that the last individual who serviced the table or removed the access cover did not exercise care to route the wire harness correctly and created a pinch point.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825014-2007-00008 |
| MDR Report Key | 893497 |
| Report Source | 08 |
| Date Received | 2007-08-07 |
| Date of Report | 2007-07-25 |
| Date of Event | 2007-07-19 |
| Date Facility Aware | 2007-07-19 |
| Report Date | 2007-07-25 |
| Date Reported to FDA | 2007-07-25 |
| Date Mfgr Received | 2007-07-26 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2007-09-25 |
| 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 |
| 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 | 3600B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 874253 |
| Manufacturer | THE KMW GROUP, SKYTRON DIVISION |
| Manufacturer Address | GRAND RAPIDS MI 49512 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-07 |