BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 6922329 · Received October 6, 2017

    Report

    Report Number
    1220063-2017-00054
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 16, 2017
    Report Date
    November 9, 2017
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K113798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN STARTED BUT NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS RECEIVED REGARDING A M540 THAT SHUT DOWN DURING TRANSPORT. AFTER REVIEWING THE LOGS, IT WAS FOUND THAT THE M540 SHUT DOWN DUE TO RUNNING OUT OF INTERNAL BATTERY CAPACITY APPROXIMATELY 24 MINUTES AFTER BEING UNDOCKED. IT COULD BE CONFIRMED THAT ALL NECESSARY ALARMS WERE GENERATED BY THE M540 PRIOR TO THE SHUTDOWN. AFTER TESTING THE DEVICE ON BATTERY POWER, IT WAS FOUND THAT THERE WAS NO FAILURE OF THE M540 AND ALL ALARMS GENERATED CORRECTLY WHEN IT WAS ALLOWED TO RUN OUT OF INTERNAL BATTERY. IT COULD BE CONFIRMED THAT THE BATTERY INSTALLED IN THE M540 HAD A MANUFACTURING DATE OF MAY 2012 WITH AN INSTALL DATE OF (B)(6) 2013. THE REDUCED RUNTIME OF THE M540 IS CONSISTENT WITH HIGH INTERNAL IMPENDENCE FROM NORMAL AGING OF THE LITHIUM-ION BATTERY PACK. THE INFINITY M540 TEST INSTRUCTIONS STATE THAT THE INTERNAL BATTERY MUST BE REPLACED EVERY 2 YEARS. THERE WAS NO DEVICE MALFUNCTION. DRAEGER CAN CONCLUDE THE M540 DEVICE DID NOT CONTRIBUTE TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2017, AT APPROXIMATELY 4:30 PM, THE M540 PATIENT MONITOR SUDDENLY SHUTDOWN WHILE TRANSPORTING A PATIENT. THE PATIENT BECAME ASYSTOLIC SOME MINUTES AFTER. AFTER THIS EVENT THE PATIENT WAS TRANSFERRED TO THE ICU AND MONITORED WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2017, AT APPROXIMATELY 4:30 PM, THE M540 PATIENT MONITOR SUDDENLY SHUTDOWN WHILE TRANSPORTING A PATIENT. THE PATIENT BECAME ASYSTOLIC SOME MINUTES AFTER. AFTER THIS EVENT THE PATIENT WAS TRANSFERRED TO THE ICU AND MONITORED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704836 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT CBK DRAEGER MEDICAL SYSTEMS, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1