MalfunctionDWQ
TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP
Received Sep 20, 2019 · Event occurred Sep 20, 2019
Report 1220948-2018-00131 · MDR key 9099881
Device
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE FAILURE. SURGEON DETECTED THE FAILURE WITH THIS DEVICE DURING PRE-USE CHECK. HOWEVER, THE PATIENT WAS ALREADY ADMINISTERED WITH GENERAL ANESTHETICS WHEN THE ISSUE WAS DETECTED. DEVICE WAS NOT USED FOR THE PROCEDURE. SURGEON HAS TO POSTPONED THE PROCEDURE SINCE THEY DID NOT HAVE ANY OTHER CONTROL UNIT IN STOCK TO COMPLETE THE PROCEDURE.
Description of Event or Problem
TRIVEX CONTROL UNIT DID NOT OPERATE BEFORE THE PROCEDURE.