TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP
Received Nov 15, 2019 · Event occurred Oct 16, 2019
Report 1220948-2018-00152 · MDR key 9330022
Device
Product problems
- Intermittent Loss of Power
- Intermittent Loss of Power
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. HOWEVER, WE WERE UNABLE TO REPLICATE THE REPORTED INCIDENT. THE HOUSING AND PLASTIC COMPONENTS WERE VISUALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. THE MDU'S OUTSIDE CABLE CONNECTOR WAS OBSERVED TO BE LOOSE. THE CABLE TIE THAT HOLDS THE CABLE MOUNT WAS OBSERVED TO BE BROKEN. WHEN A HANDPIECE WAS CONNECTED IN THE CONTROL UNIT, IT OPERATED PROPERLY ON ALL SETTINGS AND SPEEDS. THE ILLUMINATOR PUMP FUNCTIONED WITH BOTH FOOTPEDAL CONNECTION. OUR DEVICE EVALUATION COULD NOT IDENTIFY ANY DEFECT IN THIS CONTROL UNIT THAT COULD HAVE CAUSE INTERMITTENT POWER FAILURE AT THE HOSPITAL. THIS ISSUE OCCURRED ALMOST 3 YEARS AFTER BEING IN USE AT THIS HOSPITAL, BUT WAS NOT ABLE TO BE REPLICATED DURING OUR INVESTIGATION.
Description of Event or Problem
TRIVEX CONTROL UNIT SHUT DOWN INTERMITTENTLY DURING PRE-USE CHECK. THE ISSUE CONTINUED EVEN AFTER CHANGING THE HANDPIECE.