BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT CARE IICS90

    MDR report key: 5054112 · Received September 3, 2015

    Report

    Report Number
    2510954-2015-00002
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    June 29, 2015
    Report Date
    August 5, 2015
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K875270
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF NO AUDIBLE ALARM FOR AN OVER TEMPERATURE CONDITION WAS ISOLATED TO A COMPONENT FAILURE ON THE DISPLAY PCB OF THE CONTROLLER. COMPONENT DIODE CR4 WAS FOUND TO HAVE AN OPEN CONDITION. THIS DIODE ENABLES T.. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ON (B)(6) 2015, AT 11:00 AM, A BABY WITH NO PROBLEMS AFTER BIRTH, SUFFERED 1ST GRADE BURNS, RESPIRATORY PROBLEMS & LIVER FAILURE DUE TO OVERHEATING. THE BABY WAS IN AN IICS-90 INFANT CARE. WE RECEIVED A TECHNICAL REPORT 12:00 PM THAT DAY & WENT TO THE HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2015, AT 11:00 AM, A BABY WITH NO PROBLEMS AFTER BIRTH, SUFFERED 1ST GRADE BURNS, RESPIRATORY PROBLEMS & LIVER FAILURE DUE TO OVERHEATING. THE BABY WAS IN AN IICS-90 INFANT CARE. WE RECEIVED A TECHNICAL REPORT 12:00 PM THAT DAY & WENT TO THE HOSPIT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585166 INFANT CARE IICS90 INFANT RADIANT WARMER CBK DRAEGER MEDICAL SYSTEMS, INC. 7810 NA

    Patients

    Seq Age Sex Outcome Treatment
    1