BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER MARATHON

    MDR report key: 914 · Received July 22, 1992

    Report

    Report Number
    32606-1992-00001
    Event Type
    Malfunction
    Date Received
    July 22, 1992
    Report Date
    July 2, 1992
    Manufacturer
    HERMLE
    Product Code
    KSN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISHER MARATHON CENTRIFUGE KSN HERMLE 21K N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other