BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVII

    MDR report key: 6110917 · Received November 17, 2016

    Report

    Report Number
    3006340424-2016-00001
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 10, 2016
    Report Date
    August 11, 2016
    Manufacturer
    MONICA HEALTHCARE LTD
    Product Code
    HGM
    UDI-DI
    05060433670060
    PMA / PMN Number
    K140862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EVALUATION IS BEING CARRIED OUT ON NOVII POD IN THE (B)(4) BUT AT PRESENT WE CAN NOT REPEAT THE ISSUE. WE ARE AWAITING FOR THE FAILED UNIT TO BE RETURNED TO OUR FACILITY IN THE (B)(4) FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6). MONICA WAS INFORMED THERE HAD BEEN AN INCIDENT WITH A NOVII POD AT THE (B)(6) HOSPITAL IN (B)(6) WHERE A POD OVERHEATED WHILST ON CHARGE AND BEGAN EMITTING SPARKS BEFORE MELTING THE EXTERIOR POD PLASTIC. NO-ONE WAS HURT. THE POD WAS ON CHARGE IN A STOCKROOM AT THE TIME AND A JUNIOR NURSE WAS PRESENT AND HEARD A POP, FOLLOWED BY SPARKS AND SMOKE. THE L&D MANAGER DOUSED THE NOVII SYSTEM WITH A POWDER FIRE EXTINGUISHER AND THE HOSPITAL FIRE DEPARTMENT WAS CALLED. MONICA'S CLINICAL SPECIALIST, (B)(6), HAPPENED TO BE AT THE HOSPITAL AT THE TIME. THE IMMEDIATE HYPOTHESIS WAS THAT THE LITHIUM-POLYMER BATTERY WITHIN THE NOVII POD COULD BE THE CAUSE AND THE FACT THAT THE FAILURE OCCURRED DURING CHARGING, I.E. AT A TIME WHEN THE BATTERY CHEMISTRY IS MOST VOLATILE, APPEARED TO SUPPORT THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762439 NOVII NOVII POD HGM MONICA HEALTHCARE LTD 307-PT-003 500871 05060433670060

    Patients

    Seq Age Sex Outcome Treatment
    1