BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER SUPPLY

    MDR report key: 5097642 · Received September 23, 2015

    Report

    Report Number
    3015729-2015-00002
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 3, 2015
    Manufacturer
    A-DEC, INC.
    Product Code
    KLC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR SHIPPED PRODUCT, THE MANUFACTURER IS CONTACTING CUSTOMERS TO NOTIFY THEM OF THE ISSUE AND PROVIDE REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    A QUANTITY OF 173 ELECTRIC POWER SUPPLIES SHIPPED WITHOUT DIELECTRIC TESTING PER IEC 60601-1 (2012). THESE POWER SUPPLIES ARE DESIGNED AND MANUFACTURED FOR USE WITH DENTAL EQUIPMENT. BETWEEN JULY 5 AND AUGUST 26, 2015, THE PRODUCTS PASSED THE FUNCTIONAL TEST AND THE GROUND CONTINUITY TEST; HOWEVER A SERVICE ERROR PREVENTED THE APPLICATION OF HIGH VOLTAGE FOR THE DIELECTRIC TEST. THESE POWER SUPPLIES WERE SHIPPED TO CUSTOMERS WORLDWIDE. 25 WATT POWER SUPPLIES: 28.1479.00, 28.1480.00, 28.1481.00. 80 WATT POWER SUPPLIES: 47.2031.00, 28.1345.00. 300 WATT POWER SUPPLIES: 43.0260.00, 43.0261.00, 28.1435.00, 28.1436.00. THE HAZARD FOR UNTESTED PRODUCT IS ELECTRICAL DAMAGE TO EQUIPMENT, SMOKE, FIRE OR ELECTRICAL SHOCK TO PERSONS. DUE TO STANDARD ASSEMBLY INSTRUCTIONS AND 100% FUNCTIONAL TESTING, THE PROBABILITY OF A HAZARDOUS CONDITION IS REMOTE. AS OF THE DATE ON THIS REPORT, THERE HAVE BEEN NO REPORTED FIELD MALFUNCTIONS. ALL PRODUCT WITHIN THE MANUFACTURER'S CONTROL WAS QUARANTINED AND SUBSEQUENTLY TESTED. FOR SHIPPED PRODUCT, THE MANUFACTURER IS CONTACTING CUSTOMERS TO NOTIFY THEM OF THE ISSUE AND PROVIDE REPLACEMENT PRODUCT. THE MALFUNCTIONING DIELECTRIC TESTER (TF804 UNIVERSAL POWER SUPPLY DIELECTRIC TESTER) WAS REPAIRED ON AUGUST 26, 2015 AND CORRECTIVE ACTION WAS TAKEN TO ENSURE THE SERVICE ERROR COULD NOT RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629538 POWER SUPPLY KLC A-DEC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening