BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPITAL TEMP PUMP PROFESSIONAL

    MDR report key: 3240740 · Received July 22, 2013

    Report

    Report Number
    0001831750-2013-06538
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND THAT THE TEMPERATURE PUMP WAS NOT FUNCTIONING CORRECTLY DUE TO THE MAIN BOARD (PCB) BEING DAMAGED. A DAMAGED PC BOARD/HEATER WOULD RESULT IN THE DEVICE ALARMING NOTIFYING THE USER TO REMOVE THE UNIT FROM SERVICE. AN ALTERNATIVE DEVICE COULD BE USED FOR TEMPERATURE THERAPY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE UNIT IS GOING INTO OVER TEMP. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE UNIT IS GOING INTO OVER TEMP. 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
    341858 CAPITAL TEMP PUMP PROFESSIONAL PACK, HOT OR COLD, WATER CIRCULATING ILO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1