BEUDAMED
    FDA Adverse Event Other Summary report: N

    DASH 4000

    MDR report key: 1329144 · Received February 24, 2009

    Report

    Report Number
    2124823-2009-00012
    Event Type
    Other
    Date Received
    February 24, 2009
    Date of Event
    January 9, 2009
    Report Date
    February 24, 2009
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K073462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE FELT A SHOCK WHEN SHE TOUCHED THE TRIM KNOB ON THE DASH. THE NURSE WAS ADMITTED INTO THE ER FOR A COUPLE OF HOURS, COMPLAINING OF CHEST PAIN. SHE WAS DIAPHORETIC. HER CPK LEVELS WERE NORMAL AND EKG WAS NORMAL WITH SOME FLIPPED Q AND T WAVES, BUT NOTHING THAT THE DOCTOR FELT NEEDED FURTHER MONITORING. SHE DID NOT HAVE ANY EVIDENCE OF BURNS. THE NURSE REPORTED THAT THE SHOCK WENT THROUGH HER ARM AND LEG AND TOOK HER TO HER KNEES. THE CHEST PAIN REPORTEDLY RESOLVED AND THE NURSE RETURNED TO WORK. THE BIOMED DID AN ELECTRICAL SAFETY CHECK OUT ON THE DASH AND COULD NOT FIND ANY PROBLEMS WITH THE DEVICE. 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 4000 PATIENT MONITOR MHX GE HEALTHCARE 2023615-302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other