MalfunctionNTB

EPICOR ULTRACINCH LP ABLATION DEVICE

Received Sep 15, 2010 · Event occurred Aug 28, 2010

Report 1869375 · MDR key 1869375

Device

Generic name

System, Ablation

Manufacturer

St. Jude Medical

Model number

UC-LP-10

Catalog number

Lot number

Product problems

Device Displays Incorrect Message

Patient

No Patient Involvement

Narrative

Description of Event or Problem

THE EPICOR CINCH WAS CONNECTED TO THE MACHINE. DURING THE SELF TEST, THE SCREEN DISPLAYED "4 DAMAGED CELLS." I DISCONNECTED THE CINCH AND RECONNECTED THE CINCH TO MACHINE. THE MACHINE PERFORMED ANOTHER SELF TEST. AGAIN THE DISPLAY READ "4 DAMAGED CELLS." I TURNED THE MACHINE OFF, THEN REPEATED THE PROCESS. AFTER THE DAMAGED CELLS DISPLAYED THE THIRD TIME, WE REMOVED THE CINCH FROM THE FIELD AND OPENED A NEW ONE. THE NEW ONE WORKED. THE DAMAGED ONE WAS NEVER USED ON THE PATIENT.