BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOKER BOX EMERGENCY DEFIBRILLATOR ADAPTOR SYSTEM

    MDR report key: 184130 · Received August 20, 1998

    Report

    Report Number
    MW4002322
    Event Type
    Malfunction
    Date Received
    August 20, 1998
    Report Date
    August 7, 1998
    Manufacturer
    PADECO, INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DEVICE REFERRED TO AS "BOOKER BOX" WAS SOLD TO A HOSP. THE COMPLAINANT STATED THAT THE DEVICE WAS BEING PROMOTED FOR USE AS AN ADAPTER TO EXTERNAL DEFIBRILLAOTS TO ALLOW FOR INTERNAL DEFIBRILLATION AND CARDIAC ABLATION. HE STATED THAT THE MFR INFORMED HIM THE DEVICE WAS NOT APPROVED BY FDA. THE HOSP HAS SINCE RETURNED THE PRODUCT TO THE MFR. THE COMPLAINANT FAXED FDA INFO RELATED TO THE DEIVCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOKER BOX EMERGENCY DEFIBRILLATOR ADAPTOR SYSTEM DEFIBRILLATOR ADAPTOR LDD PADECO, INC. EDASI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other