BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1243610 · Received November 7, 2008

    Report

    Report Number
    1243610
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 7, 2008
    Manufacturer
    OMNICELL, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE APPROACHED OMNICELL ON NORTH SIDE OF UNIT, JUST AFTER 12 MIDNIGHT - SHE ENTERED HER USER ID WHICH OMNICELL MESSAGE STATED WAS "INVALID". THEN, AS SHE REACHED OR POSSIBLY TOUCHED THE "OK" BUTTON ON SCREEN WITH HER RIGHT INDEX FINGER, SHE FELT A "HUGE SHOCK" GO THROUGH HER RIGHT THUMB, UP HER ARM AND TO HER BACK. HER THUMB WAS REDDENED, AS IF BURNED. THE OMNICELL WENT DARK, AND THE NURSE WENT TO THE EMERGENCY ROOM FOR EVALUATION. SHE ALSO WENT TO EMPLOYEE HEALTH SERVICE IN THE MORNING. SHE WENT HOME AND WAS TAKEN OFF WORK SECONDARY TO "BACK SPASMS". SHE WAS OFF ONE NIGHT, AND CALLED IN THE NEXT NIGHT DUE TO PAIN/BACK SPASMS. SHE IS STILL OFF, AND SEEING EMPLOYEE HEALTH SERVICE TODAY FOR FOLLOW-UP.BIOMED WAS CALLED. THEY INSTRUCTED CLINICIANS TO CALL MAINTENANCE-ELECTRICIAN. ELECTRICIAN CAME UP TO ASSESS PLUGS, ETC. IN THE MORNING, AND THOUGHT "STATIC ELECTRICITY" CAUSED THE SHOCK. BIOMED CALLED AGAIN, AND CLINICAL ENGINEER CAME UP IN THE AFTERNOON TO EVALUATE.COMPANY (OMNICALL) CAME IN LATER IN THE MORNING AND REPLACED THE "OMNI BOX" . THE OMNICELL WAS PLACED BACK ON LINE. BIOMED TO FOLLOW UP TO EVALUATE THIS WITH THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DRUG / SUPPLY DISPENSING SYSTEM LNX OMNICELL, INC. OSCT; COMPUTER FOR MEDICAL STORAGE CABINET *

    Patients

    Seq Age Sex Outcome Treatment
    1 *