BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA CARE PLUS INCUBATOR

    MDR report key: 177129 · Received July 14, 1998

    Report

    Report Number
    1121732-1998-00006
    Event Type
    Malfunction
    Date Received
    July 14, 1998
    Report Date
    June 15, 1998
    Manufacturer
    OHMEDA
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS PART OF OHMEDA'S INVESTIGATION TO PREVIOUSLY REPORTED MDR 1121732-1998-00004, OHMEDA SERVICE EVALUATED ALL CARE PLUS SERVO HUMIDIFIERS IN THE HOSP WHERE THE EARLIER INCIDENT OCCURRED. DURING THIS EVALUATION, THE SERVICE REP OBSERVED THAT THE HEATING ELEMENT OF THE SUBJECT DEVICE HAD BECOME DETATCHED FROM THE HEAT SINK AND HAD SOME BROWN DISCOLORATION ON THE UNDER SIDE OF THE LID. THIS WAS NOT THE SAME LEVEL OF FAILURE AS THE EARILIER REPORT, BUT INASMUCH AS IT EXHIBITED EARLY SIGNS OF THIS FAILURE, OHMEDA IS SUBMITTING THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA CARE PLUS INCUBATOR INFANT INCUBATOR FMZ OHMEDA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other