BEUDAMED
    FDA Adverse Event Summary report: N

    OHIO CARE PLUS

    MDR report key: 2802507 · Received September 20, 2012

    Report

    Report Number
    2802507
    Date Received
    September 20, 2012
    Date of Event
    January 29, 2012
    Report Date
    September 20, 2012
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ISOLETTE DID NOT HAVE A BABY IN IT BUT WAS PLUGGED IN HEATING AND THE TEMPERATURE FAILURE ALARM CONTINUED TO INDICATE THE UNIT WAS OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHIO CARE PLUS INCUBATOR, NEONATAL FMZ OHMEDA MEDICAL 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *