TRUSAT POWER SUPPLY

Additional Manufacturer Narrative

(B)(4). NARRATIVE: GE HEALTHCARE REC'D THE TWO SAMPLES FOR INVESTIGATION. IN BOTH POWER SUPPLIES, IT WAS CONFIRMED THAT THERE WAS A BREAKAGE IN THE SOLDER JOINT THAT IS DIRECTLY CONNECTED TO THE POWER CORD MAINS CONNECTOR. THE AREA AROUND BOTH OF THE SOLDERING JOINTS DISPLAYED SIGNS OF ARCING. THE INSIDE OF THE ENCLOSURE ALSO DISPLAYED BURN MARKS. ON (B)(6) 2011, THE ROOT CAUSE OF THE BROKEN SOLDER JOINT WAS DETERMINED TO BE MECHANICAL STRESS ON THE SOLDER JOINT WHEN THE POWER CORD IS CONNECTED AND DISCONNECTED FROM THE EXTERNAL POWER SUPPLY. THE CURRENT DESIGN OF THE MECHANICAL LOCKING OF THE POWER CORD MAINS CONNECTOR ALLOWS THE TRANSFER OF STRESS FROM THE POWER CORD MAINS CONNECTOR TO THE SOLDER JOINT ON THE LIVE SIDE OF THE MAINS CONNECTOR. THE REPEATED STRESS OF CONNECTING AND DISCONNECTING THE POWER CORD FROM THE MAINS CONNECTOR LEADS TO THE BREAKAGE OF THE SOLDER JOINT. GE HEALTHCARE STOPPED SHIPPING THE AFFECTED UNITS ON (B)(4) 2010. A FIELD ACTION (B)(4) IS BEING IMPLEMENTED FOR THIS POWER SUPPLY FOR A SEPARATE ISSUE WHICH WAS REPORTED TO FDA PER 21 CFR PART 806. THE ISSUE REPORTED IN THIS MDR (BROKEN SOLDER JOINT) WILL ALSO BE CORRECTED BY THIS FIELD ACTION BECAUSE THE FIELD ACTION WILL REPLACE THE POWER SUPPLY.

Description of Event or Problem

A SITE REPORTED THAT TWO POWER SUPPLIES HAD STOPPED WORKING. THIS IS THE FIRST OF TWO MDRS. THE SITE REPORTEDLY OPENED ONE OF THE POWER SUPPLIES AND NOTED THAT THE SOLDER JOINT ON THE LIVE SIDE OF THE MAINS CONNECTOR HAD FRACTURED AND SHOWED SIGNS OF ELECTRICAL ARCING. NO INJURY WAS REPORTED.