BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE

    MDR report key: 596536 · Received April 22, 2005

    Report

    Report Number
    MW1035293
    Event Type
    Other
    Date Received
    April 22, 2005
    Date of Event
    April 19, 2005
    Report Date
    April 19, 2005
    Manufacturer
    ERBE USA, INC.
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    AFC USED AN "GASTRIC APC" SETTING PULSED MODE. PAD WAS PLACED ON LOWER BACK INSTEAD OF ON HIP DUE TO FRESH HIP REPLACEMENT INCISION. PT HAD AN AICO & PACEMAKER IN PLACE. WHEN UNIT WAS ACTIVATED THE PT WAS OBVIOUSLY AWAKENED FROM CONSCIOUS SEDATION AND FELT THE "SHOCK." ARMS JERKED EACH TIME. NO BURN TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE V10 APC GEI ERBE USA, INC. V10 300 D REF# 10140-000-

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other