PIRANHA

Description of Event or Problem

ACCORDING TO THE REPORT, THE DEVICE FAILED WITH REGARDS TO ITS INTENDED FUNCTION. THE CUSTOMER REPORTED THAT THE SUCTION PUMP UNIT ERRORED. A VISUAL MESSAGE "VACUUM BUILD-UP DEFECTIVE CHECK CONTAINERS AND TUBE SET FOR LEAKS" DISPLAYS ON THE SCREEN. THE CUSTOMER STATED THAT THE ERROR MESSAGE CAN BE CLEARED HOWEVER; THE MESSAGE DISPLAYS AND THE ALARM GOES OFF EVERY TIME THE MACHINE WAS BEING SET UP.

Additional Manufacturer Narrative

THERE HAVE BEEN NO REPORTS OF INJURIES OR UNACCEPTABLE RISKS; HOWEVER, A SIMILAR ISSUE WAS IDENTIFIED IN THE PAST TWO YEARS, WHICH WAS CLASSIFIED AS A REPORTABLE SERIOUS INJURY. THEREFORE, RICHARD WOLF GMBH CONSIDER THIS CASE TO BE A REPORTABLE MALFUNCTION.