BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 7883158 · Received September 17, 2018

    Report

    Report Number
    1220063-2018-00027
    Event Type
    Death
    Date Received
    September 17, 2018
    Date of Event
    September 13, 2018
    Report Date
    October 16, 2018
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    PMA / PMN Number
    K113798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF THE IACS LOGS, NO DEVICE MALFUNCTION COULD BE VERIFIED. THE M540 LOGS AND THE CITED DEVICE WERE REQUESTED FOR INVESTIGATION AS WELL AS ADDITIONAL INFORMATION REGARDING THE EVENT. THE CUSTOMER STATED THAT THE M540 DEVICE, M540 LOGS AND ANY FURTHER EVENT INFORMATION ARE NOT AVAILABLE. NO DEVICE MALFUNCTION COULD BE VERIFIED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IACS ART ALARMS DEACTIVATED THEMSELVES SEVERAL TIMES. THEREFORE, IT WAS NOT RECOGNIZED WHEN THE PATIENT WAS PASSING AWAY AND REQUIRED INTERVENTION. THE INVOLVED PATIENT DIED. THE EVENT OCCURRED ON (B)(6) 2018 BETWEEN 15:00 AND 15:30.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IACS ART ALARMS DEACTIVATED THEMSELVES SEVERAL TIMES. THEREFORE, IT WAS NOT RECOGNIZED WHEN THE PATIENT WAS PASSING AWAY AND REQUIRED INTERVENTION. THE INVOLVED PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723441 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT MHX DRAEGER MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death