BEUDAMED
    FDA Adverse Event Death Summary report: N

    MODEL 90478 TELEMETRY RECEIVER MODULE

    MDR report key: 1062564 · Received June 17, 2008

    Report

    Report Number
    3023361-2008-00015
    Event Type
    Death
    Date Received
    June 17, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 17, 2008
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K925510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE INITIATED AN INVESTIGATION, WHICH IS STILL UNDERWAY TO OBTAIN FACTS RELATING TO THE EVENT; DETERMINE WHETHER THERE WAS ANY PROD FAILURE, AND, IF SO, THE NATURE OF SUCH FAILURE; DETERMINE THE ROOT CAUSE OF ANY SUCH FAILURE THAT MAY HAVE OCCURRED; AND TO IDENTIFY THE APPROPRIATE CORRECTIVE ACTION, IF ANY, TO BE TAKEN. WE INTEND TO CONTINUE OUR INVESTIGATION AND PROVIDE A SUPPLEMENTAL REPORT AS APPROPRIATE.

    Description of Event or Problem · 1

    THE CUSTOMER HAS ALLEGED THAT IN 2008, A SPACELABS MODULE 90478 (TELEMETRY RECEIVER) FAILED TO ALARM WHEN THE PT EXPERIENCED LOW HEART RATE ACTIVITY AND, SUBSEQUENTLY, AN ASYSTOLE EVENT OCCURRED WITH RESPECT TO THAT PT. THE PT HAS SINCE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 90478 TELEMETRY RECEIVER MODULE NONE MHX SPACELABS HEALTHCARE 90478

    Patients

    Seq Age Sex Outcome Treatment
    1 Death