BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPONDER 1500

    MDR report key: 40617 · Received September 10, 1996

    Report

    Report Number
    2124823-1996-00007
    Event Type
    Malfunction
    Date Received
    September 10, 1996
    Date of Event
    August 14, 1996
    Report Date
    August 14, 1996
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    MKJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING DAILY CHECK OF DEVICE, "PT NOT CONNECTED" MESSAGE WAS DISPLAYED. SVC REP DUPLICATED THE CONDITION, REPAIRED DEVICE, AND CONFIRMED PROPER OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPONDER 1500 DEFIBRILLATOR, D.C. MKJ MARQUETTE ELECTRONICS, INC. 1500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other