BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS FOOTSWITCH

    MDR report key: 1944587 · Received December 19, 2010

    Report

    Report Number
    1944587
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 19, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WIRELESS FOOTSWITCH BATTERY POWER LOST AFTER SHORT USE. DISCONNECT FROM POWER SOURCE AND BATTERY POWER OK. WIRELESS FOOTSWITCH WOULD NOT WORK UNTIL IT WAS PLUGGED INTO POWER CABLE.PATIENT CARE DELAYED. FLUOROSCOPY PEDAL WOULDN'T WORK DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRELESS FOOTSWITCH X-RAY SYSTEM, CATH/ANGIO, WIRELESS FOOTSWITCH ACCESSORY JAA SIEMENS MEDICAL SOLUTIONS USA, INC. 4787805 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR