FISHER MARATHON

Description of Event or Problem

USERS SET UP CENTRIFUGE AND RECEIVED ELECTRICAL SHOCK UPON STARTING UNIT. NEITHER USER WAS INJURED NOR REQUIRED OR RECEIVED MEDICAL ATTENTION. FISHER INSTRUMENT SERVICE DIVISION PERSONNEL SERVICED UNIT UPON NOTIFICATION OF PROBLEM. UNIT HAD A DEFECTIVE LINE FILTER. UNIT REPAIRED. REPLACEMENT FILTER ORDERED AND IS TO BE INSTALLED WHEN RECEIVED. SEE ATTACHED FOR INVESTIGATION/FOLLOW-UP, RESULTSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: ELECTRICAL PROBLEM - OPEN CIRCUIT. CONCLUSION: DEVICE FAILED JUST PRIOR TO USE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.