BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM

    MDR report key: 5366131 · Received January 8, 2016

    Report

    Report Number
    MW5059296
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    November 18, 2015
    Report Date
    January 8, 2016
    Manufacturer
    DRAEGER
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IAC NOT COMMUNICATING TO, OR ALARMING AT ICS, REQUIRING TEMPORARY MONITORING ON A M540 AND ONE-TO-ONE PATIENT: NURSING STAFFING RATIO. THIS WAS LATER DETERMINED TO BE AN IACS HARD DRIVE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14893 INFINITY ACUTE CARE SYSTEM INFINITY ACUTE CARE SYSTEM CBK DRAEGER

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR