TRUSAT POWER SUPPLY
Received Jul 19, 2011 · Event occurred Jun 21, 2011
Report 3008729547-2011-00004 · MDR key 2190924
Device
Generic name
Power Supply
Manufacturer
Critikon De Mexico S. De R.l. De C.v.Product problems
- Melted
- Overheating of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AT THIS TIME, THE POWER SUPPLY HAS NOT BEEN RETURNED FOR FURTHER EVAL, HOWEVER, THERE IS A KNOWN PROBLEM WITH THIS SERIES OF POWER SUPPLIES THAT INCLUDES A FAILURE MODE SIMILAR TO THAT REPORTED. THE EVAL OF OTHER INCIDENTS THAT DISPLAYED THIS PROBLEM IS THE FOLLOWING: THE ROOT CAUSE WAS IDENTIFIED TO BE A DESIGN PROBLEM WITH THE POWER SUPPLY, PROVIDING INADEQUATE PROTECTION AGAINST OVERHEATING OF ELECTRICAL COMPONENTS (DUE TO AC MAIN SUPPLY FLUCTUATION, COMPONENT FAILURE OR A SHORT IN POWER CORD / DEVICE). GE HEALTHCARE STOPPED SHIPPING THE AFFECTED UNITS ON 12/20/2010, AND IS IMPLEMENTING A FIELD ACTION FOR AFFECTED UNITS. GE HEALTHCARE HAS REPORTED THE ISSUE TO FDA PER 21 CFR PART 806.
Description of Event or Problem
IT WAS REPORTED THAT A TRUSAT EXTERNAL POWER SUPPLY OVERHEATED AND THE EXTERNAL ENCLOSURE SHOWED EVIDENCE OF MELTING. THE AFFECTED DEVICE WAS REMOVED FROM SERVICE. NO INJURY WAS REPORTED.