BEUDAMED
    FDA Adverse Event Death Summary report: N

    DASH 4000

    MDR report key: 10135446 · Received June 9, 2020

    Report

    Report Number
    3008729547-2020-00002
    Event Type
    Death
    Date Received
    June 9, 2020
    Date of Event
    May 24, 2020
    Report Date
    September 29, 2020
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    MHX
    PMA / PMN Number
    K073462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A1-4: THE CUSTOMER DECLINED TO PROVIDE THE REQUESTED INFORMATION. IT WAS REPORTED THAT ON THE MORNING ON (B)(6) 2020, THE DASH 4000 DID NOT BROADCAST AN AUDIBLE ASYSTOLE ALARM IN THE PATIENTS ROOM. THE PATIENT WAS RESUSCITATED HOWEVER, EXPIRED ON 26 MAY 2020. THE CUSTOMER BIOMED ENGINEER NOTED ONLY A CLICKING SOUND WHEN TESTING THE DEVICE. THE CUSTOMER DID NOT ALLOW GE HEALTHCARE (GEHC) ACCESS TO THE DEVICE TO DOWNLOAD LOG FILES OR PERFORM ADDITIONAL TESTING. THEY ALSO DECLINED TO ANSWER ADDITIONAL CLINICAL AND TECHNICAL QUESTIONS RELATED TO THE EVENT. AT AROUND THE SAME TIME OF THE EVENT, THE CIC CENTRAL STATION (TO WHICH THE DASH 4000 WAS NETWORKED) SHUT DOWN DUE TO AN UNINTERRUPTIBLE POWER SUPPLY (UPS) FAILURE. GEHC ENGINEERING REVIEWED THE CIC LOG FILES WHICH SHOWED THAT THE PATIENT WAS ADMITTED AT 05:58 ON (B)(6) 2020. THE CIC SHUT DOWN AT 07:05 AND FUNCTION WAS RESTORED AT 10:22 AFTER THE UPS BATTERY WAS REPLACED. AT 10:23, THE LOG FILES SHOWED A WARNING-LEVEL BRADY ALARM WAS ASSERTED FOR WHICH THERE IS A BOTH VISUAL AND AUDIBLE NOTIFICATION AT THE CIC. ADDITIONAL ALARMS, INCLUDING HR LO, BRADY AND PAUSE, WERE ASSERTED AND AT 10:31, A CRISIS-LEVEL ASYSTOLE ALARM WAS PROVIDED. GEHC HAS CONCLUDED THAT THE LOSS OF AUDIO FUNCTION AT THE DASH 4000 WAS LIKELY CAUSED BY A HARDWARE COMPONENT WEAR OUT OF THE 2KX8 SERIAL EEPROM LOCATED ON THE DASH MAIN CPU BOARD. THIS DASH 4000 WAS MANUFACTURED IN 2010. GEHC PREVIOUSLY INFORMED CUSTOMERS THAT, EFFECTIVE 30 JUNE 2019, DEVICES WITH THIS PRODUCT CODE WOULD BE AT END OF PRODUCT AND SERVICE SUPPORT STATUS.

    Additional Manufacturer Narrative · 1

    UDI NOT REQUIRED. LEGAL MANUFACTURER: (B)(4). GE HEATHCARE'S INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DASH 4000 DID NOT ALARM WHEN THE PATIENT EXPERIENCED A CHANGE IN CONDITION. THE PATIENT WAS TRANSFERRED TO ICU AND EXPIRED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599168 DASH 4000 MONITOR, PHYSIOLOGICAL, PATIENT (WIT MHX CRITIKON DE MEXICO S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death