BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS COMPRESSION SYSTEM

    MDR report key: 3192540 · Received June 19, 2013

    Report

    Report Number
    3006451981-2013-00194
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 06/18/2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN SCD CONTROLLER. THE CUSTOMER STATES THE BATTERY IS NOT CHARGING. THE CONTROLLER WAS SENT TO COVIDIEN SERVICE CENTER FOR REPAIR. UPON TRIAGE, A SERVICE TECH FOUND THAT THERE ARE BURNED COMPONENTS INSIDE AND MELTING OF THE OUTER CASE IS VISIBLE. THE CUSTOMER REPORTS THERE WAS NO IMPACT TO THE USER AND THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279241 SCD EXPRESS COMPRESSION SYSTEM SCD CONTROLLER JOW COVIDIEN 9525 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK