BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPONDER 1500

    MDR report key: 40615 · Received September 10, 1996

    Report

    Report Number
    2124823-1996-00009
    Event Type
    Malfunction
    Date Received
    September 10, 1996
    Date of Event
    August 12, 1996
    Report Date
    August 12, 1996
    Manufacturer
    MARQUETTE ELECTRONICS, INC.
    Product Code
    MKJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DISPLAY WOULD INTERMITTENTLY BLANK. NO REPORTED PT INVOLVEMENT. SVC REP WAS ABLE TO DUPLICATE REPORTED CONDITION. DEVICE WAS REPAIRED AND PROPER OPERATION COFIRMED.

    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