There was no patient involvement.Livanova deutschland manufactures the s5 double head pump.The incident occurred in muenchen, germany.The livanova field service representative replaced the pump with another.The affected device was returned back to the manufacturer site for repair.The reported issue was confirmed and slight signs of wear were found.The motor control board, the motor end stage board and the pump head were replaced and the problem could be solved.The motor control board, the motor end stage board were replaced as per equipment maintenance intervention prevention.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|