BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANDA IRES WARMER

    MDR report key: 23134787 · Received September 24, 2025

    Report

    Report Number
    2112667-2025-07504
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 27, 2025
    Report Date
    March 19, 2026
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMT
    PMA / PMN Number
    K123309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. . LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE¿S (GEHC) INVESTIGATION HAS BEEN COMPLETED, AND THE ROOT CAUSE IS THE USER NOT PERFORMING THE PRE-USE CHECKOUT PROCEDURE TO ENSURE THE MONITOR SHELF IS PROPERLY SECURED BEFORE MOVING THE DEVICE WITH THE MONITOR SHELF ACCESSORY. WHEN THE GE HEALTHCARE FIELD ENGINEER (FE) FIRST VISITED THE SITE, THE DOVETAIL RAIL AND INSTRUMENT SHELF MOUNT WERE FOUND TO BE DAMAGED, LIKELY DUE TO IMPACT WITH A DOOR FRAME DURING TRANSPORT. IT WAS IDENTIFIED THAT THE PRE-USE CHECKOUT, AS SPECIFIED IN THE PANDA USER MANUAL WAS NOT PERFORMED TO VERIFY THAT THE INSTRUMENT SHELF WAS PROPERLY SECURED. THROUGH TESTING AND FITMENT CHECKS, THE FE CONFIRMED THAT, DESPITE THE DAMAGE, THE INSTRUMENT SHELF CAN STILL BE SECURELY MOUNTED TO THE RAIL IF PROPERLY RETIGHTENED. GE HEALTHCARE ISSUED A LETTER ADVISING THE CUSTOMER TO CHECK THE INSTRUMENT SHELF MOUNTING AND THE DOVETAIL RAIL FOR DAMAGE AND ENSURE THE SHELF IS PROPERLY SECURED. THE RISK ANALYSIS DETERMINED THAT NO ADDITIONAL MITIGATIONS ARE AVAILABLE TO REDUCE THE RISK, AND THE RISK HAS BEEN REDUCED AS FAR AS POSSIBLE. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A PATIENT SUFFERED A BRUISE ON THE RIGHT SIDE OF THE HEAD WHILE A PANDA IRES WARMER WAS IN USE. ALLEGEDLY, AN INSTRUMENT SHELF DISENGAGED FROM THE PANDA AND HIT THE PATIENT ON THE HEAD. THE PATIENT WAS SENT FOR A SCAN AND WAS DISCHARGED FROM THE NEONATAL UNIT. THERE WAS NO PATIENT SEQUELAE. GE HEALTHCARE WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385290 PANDA IRES WARMER WARMER, INFANT RADIANT FMT DATEX-OHMEDA, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Unknown Other