MalfunctionFXM
1188 HD CCU
Received Apr 18, 2011 · Event occurred Mar 25, 2011
Report 2936485-2011-00240 · MDR key 2070380
Device
Product problems
- Loss of Power
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT SHUTS OFF.
Additional Manufacturer Narrative
THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE WAS CONFIRMED. THE PRODUCT WAS SUBJECTED TO FUNCTIONAL TESTING. A DEFECTIVE INTEGRATED CIRCUIT WAS DISCOVERED ON THE MAIN CIRCUIT BOARD. THE ROOT CAUSE OF THE REPORTED FAILURE WAS TRACED TO THIS DEFECTIVE COMPONENT. IN SUM, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.