BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWR CORD, HOS GR,IEC320

    MDR report key: 9187431 · Received October 14, 2019

    Report

    Report Number
    2184149-2019-00187
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    October 1, 2019
    Report Date
    February 28, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067014573
    PMA / PMN Number
    K141050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D1, D10, G4, G7, H2, H3, H6 ONE HOSPITAL GRADE POWER CORD PN 41-03089-001 WAS RECEIVED INTO THE LAB FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE FIELD REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED AS NO ABNORMALITIES WERE IDENTIFIED. ALL ELECTRICAL CONTACT PINS AND CONNECTOR BODIES ARE FREE OF PHYSICAL DAMAGE AND DISCOLORATION DUE TO ELECTRICAL ARCING.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    PRIOR TO A PROCEDURE, THE POWER CONDITIONER POWER CABLE SPARKED WHEN SYSTEM WAS TURNED ON. THE CONDITIONER WAS REMOVED AND SYSTEM POWERED UP NORMALLY. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979726 PWR CORD, HOS GR,IEC320 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. EE3000 5902000 05415067014573

    Patients

    Seq Age Sex Outcome Treatment
    1