BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESUSCITAIRE RADIANT WARMER

    MDR report key: 15787752 · Received November 14, 2022

    Report

    Report Number
    2510954-2022-00010
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    November 4, 2022
    Report Date
    January 2, 2023
    Manufacturer
    DRAEGER MEDICAL INFANT CARE, INC.
    Product Code
    FMT
    PMA / PMN Number
    K120642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED STATING THAT A COOL COMPRESS WAS APPLIED ON THE SITE OF THE BURN, NO MEDICAL INTERVENTION WAS REQUIRED. PER THE NURSE THAT REPORTED THE EVENT, THE RESUSCITAIRE WAS IN MANUAL MODE DURING THE EVENT AND NO SKIN PROBES WERE BEING USED. "IT HAD BEEN TURNED UP (I'M GOING TO PRESUME TO MAX BUT I CAN'T REMEMBER)." IT IS UNKNOWN IF THE DEVICE WAS PREWARMED PRIOR TO USE. THE UNIT DID NOT ALARM AS THE PATIENT WAS UNDER THE HEATER FOR LESS THAN 5 MINUTES, NOT LONG ENOUGH FOR THE 'CHECK PATIENT' ALARM [THE CHECK PATIENT ALARM IS PROVIDED AFTER 10 MINUTES OF USE UNDER MANUAL MODE]. A DRAEGER TECHNICIAN WENT ON SITE AND CONFIRMED THERE WAS NO DEVICE MALFUNCTION, THE TEMPERATURE OUTPUT WAS WITHIN SPECIFICATION. THE DEVICE WAS BEING USED IN MANUAL MODE WHICH REQUIRES CONTINUOUS MONITORING OF INFANT SKIN TEMPERATURE TO AVOID UNDER OR OVER HEATING. FROM THE RESUSCITAIRE INSTRUCTION FOR USE (IFU): CAUTION THE ATTENDING PHYSICIAN SHOULD PRESCRIBE THE TEMPERATURE SETTINGS. ROUTINELY MONITOR THE PATIENT TEMPERATURE ACCORDING TO THE ATTENDING PHYSICIAN ORDERS OR ESTABLISHED HOSPITAL PROTOCOL. FAILURE TO DO SO COULD RESULT IN PATIENT INJURY. WARNING TO AVOID OVERHEATING OR UNDERHEATING, CONTINUOUSLY MONITOR, AND MANUALLY OR AUTOMATICALLY CONTROL THE INFANT SKIN TEMPERATURE. FAILURE TO DO SO COULD RESULT IN PATIENT INJURY. NOTE USE MANUAL MODE ONLY FOR SHORT-TERM WARMING WITH NURSING PERSONNEL IN CONSTANT ATTENDANCE. H3 OTHER TEXT : A DRAEGER TECHNICIAN WENT ON SITE AND CONFIRMED THERE WAS NO DEVICE MALFUNCTION, THE TEMPERATURE OUTPUT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A RESUSCITAIRE RADIANT WARMER WAS INVOLVED IN AN INCIDENT, IN WHICH THE HEATER HAS CAUSED BURNS TO THE FACE OF A PATIENT. THE PATIENT WAS MOVED FROM THIS UNIT TO A DIFFERENT ONE AND RECOVERED. THE BIOMED WAS NOT SURE IF ANY MEDICAL INTERVENTION WAS REQUIRED FOR THE REPORTED BURNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A RESUSCITAIRE RADIANT WARMER WAS INVOLVED IN AN INCIDENT, IN WHICH THE HEATER HAS CAUSED BURNS TO THE FACE OF A PATIENT. THE PATIENT WAS MOVED FROM THIS UNIT TO A DIFFERENT ONE AND RECOVERED. THE BIOMED WAS NOT SURE IF ANY MEDICAL INTERVENTION WAS REQUIRED FOR THE REPORTED BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357136 RESUSCITAIRE RADIANT WARMER INFANT RADIANT WARMER FMT DRAEGER MEDICAL INFANT CARE, INC. MU20503

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention