BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRITIKON BLOOD PRESSURE CUFF

    MDR report key: 2425200 · Received January 20, 2012

    Report

    Report Number
    MW5023892
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 4, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    DXN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN PT'S SURGERY COMPLETED AND DRAPES TAKEN DOWN. THE PT'S RIGHT FOREARM WAS NOTED TO BE EDEMATOUS DISCOLORED AND BLISTERED. THE SETTING WAS ON MANUAL AND WAS NOT BEING USED AT THE TIME, THE CUFF WAS ALSO DISCONNECTED APPROX. 10 MIN BEFORE THE DRAPES CAME OFF AND THE CUFF DID NOT DEFLATE. THERE WERE IVS PRESENT IN THE RIGHT FOREARM/HAND , AN ARTERIAL LINE WHICH WAS NOT FUNCTIONING WELL. THE PT REQUIRED A FASCIOTOMY AND A VAC DRESSING WAS APPLIED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRITIKON BLOOD PRESSURE CUFF BP CUFF DXN GE HEALTHCARE REF 2404

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention