BEUDAMED
    FDA Adverse Event Death Summary report: N

    MODULUS SE

    MDR report key: 3688181 · Received February 28, 2014

    Report

    Report Number
    2112667-2014-00030
    Event Type
    Death
    Date Received
    February 28, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 4, 2014
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K863207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS MANUFACTURED IN 1995. MONTH IS NOT KNOWN. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE (B)(6) POLICE DEPARTMENT, ON BEHALF OF THE CORONER, REQUESTED GE HEALTHCARE PERFORM A CHECKOUT OF THE EQUIPMENT. IT WAS REPORTED THAT A CHILD CODED DURING A DENTAL PROCEDURE AND SUBSEQUENTLY DIED. THERE WAS NO ALLEGATION OF EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125336 MODULUS SE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Death