TRUSAT POWER SUPPLY
Received Feb 8, 2011 · Event occurred Dec 23, 2010
Report 9613557-2011-00003 · MDR key 2020436
Device
Product problems
- Device Inoperable
- Temperature Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE POWER SUPPLY WAS RETURNED FOR INVESTIGATION AND THE REPORTED COMPLAINT WAS CONFIRMED. 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 (B)(4) 2010, AND PLANS TO IMPLEMENT A FIELD ACTION FOR AFFECTED UNITS. GE HEALTHCARE WILL BE REPORTING THE ISSUE TO FDA PER 21 CFR PART 806.
Description of Event or Problem
IT WAS REPORTED THAT A TRUSAT EXTERNAL POWER SUPPLY STOPPED WORKING AND WAS WARM TO THE TOUCH. NO INJURY WAS REPORTED.
Remedial action
- Recall