MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-08-10 for SKYTRON ELITE 6500 6500NB manufactured by Kmw Group, Skytron Div.
[20023254]
Excessive smoke emanating from 120 volt power cord.
Patient Sequence No: 1, Text Type: D, B5
[20041851]
In 2006, victory products received a call from hosp and the reported smoke emanating from the power cord of a 6500 table. The skytron rep proceeded to the facility to perform an evaluation of the situation. His preliminary examination revealed a burnt or melted power cord assembly. The cause of the burnt power cord appears to have been induced by oxidation or corrosion of the table base power cord receptable connector pins. The increased resistance lead to excessive heat and subsequent melting of the female end of the power cord. During his investigation, he learned that the cleaning practices of the facility likely caused the corrosion to the connector. The cleaning staff spray cleaning fluid directly onto the base of the table and connectors against the mfrs maintenance and usage instructions. Routine preventative maintenance by in house personnel did not detect the corrosion or replace the parts. Additionally, skytron requires that when using spray cleaners do not spray fluids directly into a electrical connectors or micro switches. This info is clearly stated in the product's operators manual. Skytron is working with victory products and alexandria hosp to retrofit the power cord to a sealed type non detachable style due to their unwillingness to change cleaning practices. We are still in this process and we will file a follow up report when complete with conclusive action.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825014-2006-00008 |
| MDR Report Key | 771900 |
| Report Source | 07 |
| Date Received | 2006-08-10 |
| Date of Report | 2006-08-09 |
| Date of Event | 2006-07-26 |
| Date Facility Aware | 2006-07-26 |
| Report Date | 2006-08-09 |
| Date Reported to FDA | 2006-08-09 |
| Date Mfgr Received | 2006-07-26 |
| Device Manufacturer Date | 1994-11-01 |
| Date Added to Maude | 2006-10-24 |
| 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 | 2-27-17 HONGO, MRK BLDG. 5F BUNKYO-KU |
| Manufacturer City | TOKYO 113-0033 |
| Manufacturer Country | JA |
| Manufacturer Postal | 113-0033 |
| Manufacturer Phone | 8133815319 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL TABLE |
| Product Code | BWN |
| Date Received | 2006-08-10 |
| Model Number | ELITE 6500 |
| Catalog Number | 6500NB |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 759678 |
| Manufacturer | KMW GROUP, SKYTRON DIV |
| Manufacturer Address | * GRAND RAPIDS MI 49512 US |
| Baseline Brand Name | SKYTRON |
| Baseline Generic Name | SURGICAL TABLE |
| Baseline Model No | ELITE 6500 |
| Baseline Catalog No | 6500NB |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-10 |