BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE WARMER

    MDR report key: 3829386 · Received March 18, 2014

    Report

    Report Number
    1121732-2014-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Report Date
    February 17, 2014
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    PMA / PMN Number
    K123309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    STANDARD PROCEDURE FROM NRP (NEONATAL RESUSCITATION PROGRAM) DICTATES THAT AT LEAST TWO CLINICIANS CERTIFIED IN NEONATAL RESUSCITATION MUST BE IN ATTENDANCE DURING EVER RESUSCITATION. THE CLINICIANS DO NOT LEAVE THE BEDSIDE OF THE INFANT UNTIL THE BABY IS STABLE OR TRANSPORTED TO THE NICU. IN ADDITION, PULSE OXIMETRY MONITORING RESULTS ARE DISPLAYED ON THE MONITOR. PRELIMINARY FINDINGS WERE THAT THE DEFAULT ALARM WAS WORKING; HOWEVER, THE USER-ADJUSTED ALARM SETTING IS WHAT APPEARED TO HAVE FAILED. THIS USER-ADJUSTED ALARM SETTING IS INDEPENDENT OF THE VALUES DISPLAYED ON THE MONITOR. THE PATIENT'S ACTUAL OXYGEN SATURATION AND PULSE RATE PARAMETERS ARE DISPLAYED CORRECTLY ON THE WARMER DEVICE'S SCREEN. THE USER-ADJUSTED ALARM LIMITS BEING DISPLAYED MAY BE DIFFERENT THAN WHAT THE SYSTEM USES FOR ALARM ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GIRAFFE WARMER SPO2 ALARM WAS NOT WORKING. THE ISSUE WAS DISCOVERED BY THE HOSPITAL BIOMEDICAL ENGINEER DURING PREVENTIVE MAINTENANCE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159699 GIRAFFE WARMER INFANT RADIANT WARMER FMT OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1