BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DASH 3000

    MDR report key: 1181084 · Received September 29, 2008

    Report

    Report Number
    2124823-2008-00075
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 28, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K073462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD ALREADY BEEN DISCHARGED, AND WAS READY TO BE SENT HOME, BUT HE WAS STILL WEARING HIS APEX PRO CH TRANSMITTER. JUST BEFORE HE WAS TO BE RELEASED, HE COMPLAINED OF CHEST PAIN. THE NURSES USED A DEFIBRILLATOR TO REVIVE THE PT. DURING THIS TIME, THEY HAD TRIED TO RE-ADMIT THE PT TO THE DASH IN COMBO MODE. THEY SELECTED "ECG SOURCE" IN THE MENU, BUT ALLEGEDLY DID NOT GET A LIST OF TTX#'S TO CHOOSE. AFTER THEY REVIVED THE PATIENT, AND HE HAD A GOOD HR, THEY AGAIN LOOKED AT THE DASH AND IT WAS STILL WAITING FOR A TTX LIST FROM THE CIC. IT WAS REPORTED THAT THE DASH HAD BEEN WAITING FOR THE TTX LIST FOR AT LEAST 20 MINS. THE PT HAS SINCE BEEN TRANSFERRED TO THE ICU. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH 3000 PATIENT MONITOR MHX GE HEALTHCARE 2035598-108

    Patients

    Seq Age Sex Outcome Treatment
    1