BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCD RESPONSE, JAPAN

    MDR report key: 3899720 · Received June 4, 2014

    Report

    Report Number
    1717344-2014-00478
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    THE CUSTOMER STATES THAT PRIOR TO USE ON A PATIENT, THE POWER CABLE FOUND DAMAGED. NO PATIENT INVOLVEMENT. THE UNIT WAS SENT OT A COVIDIEN SERVICE CENTER FOR REPAIR. UPON TRIAGE, A SERVICE TECH FOUND EXPOSED COPPER WIRES ON THE POWER CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327179 SCD RESPONSE, JAPAN SCD CONTROLLER JOW COVIDIEN 73267 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK