BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPONDER 1250

    MDR report key: 41613 · Received September 25, 1996

    Report

    Report Number
    2124823-1996-00012
    Event Type
    Malfunction
    Date Received
    September 25, 1996
    Date of Event
    August 23, 1996
    Report Date
    August 23, 1996
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    MKJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RETURNED DEVICE TO MFR WITH A NOTE ATTACHED STATING THE DEVICE DID NOT WORK. CONTACT WITH CUSTOMER REVEALED NO PT INVOLVEMENT, ISSUE OCCURRED DAILY DURING DAILY CHECK OF DEVICE. MFG PERSONNEL REPAIRED DEVICE AND CONFIRMED PROPER OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPONDER 1250 DEFIBRILLATOR DC MKJ MARQUETTE ELECTRONICS, INC. 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other