BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE ISOLETTE

    MDR report key: 9171649 · Received October 9, 2019

    Report

    Report Number
    9171649
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 27, 2019
    Manufacturer
    DATEX-OHMEDA INC
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT WAS PLACED IN ISOLETTE FOR 10 DAYS AND WEIGHED EACH NIGHT. ISOLETTE WAS THEN CHANGED TO A DIFFERENT ONE AND WHEN INFANT WAS WEIGHED, WEIGHT GAIN OF ALMOST (B)(6)GRAMS WAS NOTED. INFANT REWEIGHED ON SEVERAL OF THE UNIT'S INFANT SCALES AND THEN A RADIANT WARMER. ALL OF THE SCALES WERE SIMILAR IN WEIGHT EXCEPT FOR THE ISOLETTE. ISOLETTE REMOVED FROM UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965252 GE HEALTHCARE ISOLETTE INCUBATOR, NEONATAL FMZ DATEX-OHMEDA INC

    Patients

    Seq Age Sex Outcome Treatment
    1