BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAMPION

    MDR report key: 2473541 · Received February 23, 2012

    Report

    Report Number
    2473541
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    February 19, 2012
    Report Date
    February 22, 2012
    Manufacturer
    CHAMPION MFG INC.
    Product Code
    GBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A BRAND NEW ELECTRIC CARDIAC CHAIR WAS JUST INTRODUCED INTO THE HOSPITAL FOR OUR POST-SURGICAL CARDIAC PATIENTS. THE PATIENT WAS PLACED FROM THE BED TO THE NEW CHAIR. THE CARDIAC MONITOR DISPLAYED SEVERE 60 CYCLE INTERFERENCE, THUS MAKING IT IMPOSSIBLE TO PROPERLY DISPLAY THE EKG TRACING ON THE PHYSIOLOGICAL MONITOR. THE PATIENT WAS REMOVED FROM THE CHAIR AND THE 60 CYCLE AC (ALTERNATE CURRENT) INTERFERENCE DISAPPEARED.======================MANUFACTURER RESPONSE FOR 54P ELECTRIC CARDIAC CHAIR, CHAMPION (PER SITE REPORTER)======================WE SPOKE WITH AN ENGINEER AT CHAMPION MFG, INC. AND HE SAID THAT THIS DEVICE DIDN'T HAVE AN EMI (ELECTROMAGNETIC INTERFERENCE) CERTIFICATE. THEY ARE AWARE OF THE PROBLEM OF THE MONITOR INTERFERENCE. HE RESPONDED TO US THEY HAVE NO INTENTION OF ATTEMPTING TO CORRECT THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHAMPION 54P ELECTRIC CARDIAC CHAIR GBB CHAMPION MFG INC. 54P *

    Patients

    Seq Age Sex Outcome Treatment
    1 *