BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHYSIO-CONTROL

    MDR report key: 509608 · Received February 4, 2004

    Report

    Report Number
    509608
    Event Type
    Other
    Date Received
    February 4, 2004
    Date of Event
    October 1, 2003
    Report Date
    November 1, 2003
    Manufacturer
    MEDTRONIC PHYSIO-CONTROL
    Product Code
    LDD
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON COMPLETION OF AN EVOKED POTENTIAL PROCEDURE, A PT WAS TRANSFERED BACK TO THEIR BED ON A TELEMETRY FLOOR. WHILE TRANSFERING THE PT BETWEEN THE GURNEY AND THE BED, THE DEFIBRILLATOR CHARGE BUTTON WAS BUMPED AGAINST A BED RAILING CAUSING THE DEVICE TO CHARGE. HANDS OFF ELECTRODE PADS WERE IN PLACE AND THE DEFIBRILLATOR CHARGED TO 360 JOULES. A NURSING STUDENT ASSISTING WITH THE TRANSFER ATTEMPTED TO REPOSITION THE DEFIBRILLATOR AND INADVERTENTLY HIT THE SHOCK SWITCH, DELIVERING THE CHARGE TO THE AWAKE PT. WHILE THE PT SUFFERED SIGNIFICANT DISCOMFORT, THEIR CARDIAC RHYTHM FOLLOWING THE SHOCK WAS NORMAL AND NO INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO-CONTROL DEFIBRILLATOR LDD MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other