BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR SHIELDS

    MDR report key: 2802733 · Received September 20, 2012

    Report

    Report Number
    2802733
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    April 26, 2012
    Report Date
    September 20, 2012
    Manufacturer
    HILL-ROM
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INCUBATOR DID NOT HAVE A BABY IN IT BUT WAS PLUGGED IN BEING HEATED AND THE ALARM THAT INDICATES A POWER PROBLEM WAS ACTIVATED. THIS FACILITY HAS HAD ANOTHER INCUBATOR WITH A SIMILAR PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELDS INCUBATOR, NEONATAL TRANSPORT FMZ HILL-ROM C300-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *