BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD EXPRESS COMPRESSION SYSTEM

    MDR report key: 3897025 · Received May 16, 2014

    Report

    Report Number
    1717344-2014-00424
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. 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) 2014 THAT A CUSTOMER HAD A NON-SPECIFIC ISSUE WITH AN SCD CONTROLLER. THE UNIT WAS RETURNED TO A LOCAL COVIDIEN SERVICE CENTER AND A SERVICE TECH FOUND THAT THE POWER CORD WAS CUT EXPOSING COPPER WIRING THAT WAS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294535 SCD EXPRESS COMPRESSION SYSTEM SCD CONTROLLER JOW COVIDIEN 9525 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK