SKYTRON
Received Aug 10, 2006 · Event occurred Jul 26, 2006
Report 1825014-2006-00008 · MDR key 771900
Device
Generic name
Surgical Table
Manufacturer
Kmw Group, Skytron DivModel number
ELITE 6500Catalog number
6500NB
Lot number
*
Product problems
- Corroded
- Inadequate Service
- Smoking
Patient
NA
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
EXCESSIVE SMOKE EMANATING FROM 120 VOLT POWER CORD.
Additional Manufacturer Narrative
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.
Remedial action
- Inspection