BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLAR CARE

    MDR report key: 2491469 · Received March 12, 2012

    Report

    Report Number
    2491469
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    March 10, 2012
    Report Date
    March 12, 2012
    Manufacturer
    BREG INC.
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS UP IN A CHAIR WITH THE POLAR CARE UNIT ON KNEE. THE POLAR CARE WAS NOTED TO BE LEAKING AT THE TUBING/ PAD CONNECTION POINT. THE PATIENT'S KNEE DRESSING, GOWN, AND SHEET ON CHAIR WAS FOUND TO BE COMPLETELY SOAKED. THE PHYSICIAN WAS NOTIFIED, THE PATIENT'S GOWN WAS CHANGED, THE DRESSING WAS CHANGED, AND A NEW POLAR CARE UNIT WAS PLACED.======================MANUFACTURER RESPONSE FOR POLAR CARE CUBE, POLAR CARE (PER SITE REPORTER).======================WE PLAN TO EMAIL SHIPPING LABEL TODAY TO RETURN THE DEVICE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CARE POLAR CARE CUBE ILO BREG INC. * 221257660

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR