BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANDA IRES WARMER

    MDR report key: 23680523 · Received December 1, 2025

    Report

    Report Number
    2112667-2025-09336
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    November 3, 2025
    Report Date
    March 26, 2026
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMT
    UDI-DI
    00840682152716
    PMA / PMN Number
    K201628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE¿S (GEHC) INVESTIGATION HAS BEEN COMPLETED. AN ON-SITE REVIEW CONFIRMED THAT THE WARMER FUNCTIONED AS INTENDED, WITH NO MALFUNCTION, NOR SHARP EDGES. THERE WAS NO PRODUCT ROOT CAUSE AS THE DEVICE FUNCTIONED AS DESIGNED AND THERE WAS NO DESIGN FLAW. THE INCIDENT WAS CAUSED BY SITUATIONAL FACTORS -EMERGENCY SITUATION, CHAOTIC CONDITIONS, AND HUMAN URGENCY. THESE CIRCUMSTANCES LED TO UNCOORDINATED ACTIONS, BUT THEY DO NOT INDICATE ANY FAILURE IN EXISTING PROCESSES OR STANDARD OPERATING PROCEDURES. 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.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: NO HEALTHCARE PROFESSIONAL INFORMATION PROVIDED TO DATE. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED A MIDWIFE SUFFERED A HAND LACERATION REQUIRING SURGICAL INTERVENTION AFTER ACCESSING A DRAWER ON A PANDA WARMER. IT WAS REPORTED THAT DURING ACTIVE NEWBORN RESUSCITATION, A NURSE AND MIDWIFE WERE POSITIONED ON OPPOSITE SIDES OF THE PANDA WARMER THAT HAS DRAWERS THAT ALLOW FOR SIMULTANEOUS ACCESS FROM BOTH SIDES. IT WAS ALLEGED THAT THE MIDWIFE HAD THEIR HAND INSIDE THE DRAWER, WHILE THE NURSE ACCESSED THE DRAWER FROM THE OPPOSITE SIDE, PULLING IT TOWARDS THEMSELVES. AS A RESULT, THE MIDWIFE'S LEFT LITTLE FINGER SUSTAINED AN APPROXIMATE 15MM LACERATION EXTENDING TO THE TENDON REQUIRING SURGICAL REPAIR. 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
    2135792 PANDA IRES WARMER WARMER, INFANT RADIANT FMT DATEX-OHMEDA, INC. NA 00840682152716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention