BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIP'S CHILDREN'S MEDICAL VENTURES

    MDR report key: 2622873 · Received June 8, 2012

    Report

    Report Number
    MW5025861
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Date of Event
    May 19, 2012
    Report Date
    June 8, 2012
    Manufacturer
    PHILIPS AVENT
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT TRANSPORT MATTRESS IS USED TO TRANSPORT PREMATURE INFANTS FROM LABOR AND DELIVERY TO NICU TO BEGIN CARE. THE ACTIVATOR DISC INSIDE THE MATTRESS DID NOT ACTIVATE AND THE MATTRESS DID NOT WARM. THERE WERE 2 MATTRESSES AVAILABLE TO USE AND NEITHER ONE WOULD WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIP'S CHILDREN'S MEDICAL VENTURES WARMER IMD PHILIPS AVENT 022412

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA