BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPITAL CONVECTIVE PATIENT

    MDR report key: 3061837 · Received April 16, 2013

    Report

    Report Number
    0001831750-2013-03367
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT IS OUTSIDE OF DESIGN LIFE AND WILL BE SCRAPPED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE UNIT HAD EXPOSED WIRES ON THE POWER CORD. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162013 CAPITAL CONVECTIVE PATIENT SYSTEM, THERMAL REGULATING DWJ STRYKER MEDICAL-KALAMAZOO TC3000

    Patients

    Seq Age Sex Outcome Treatment
    1