BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTERIK

    MDR report key: 56483 · Received August 23, 1996

    Report

    Report Number
    56483
    Event Type
    Malfunction
    Date Received
    August 23, 1996
    Date of Event
    October 23, 1995
    Report Date
    October 26, 1995
    Manufacturer
    NEOTERIK
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BATTERY CHARGER AND CONVERTER FOR TB MASK. CONVERTER BOX OVERHEATED AND MELTING OCCURRED ON PLASTIC CASING. A SECOND CONVERTER BOX, SAME MODEL# DRAINED BATTERY INSTEAD OF CHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTERIK BATTERY CHARGER AND CONVERTER FXX NEOTERIK 95150 JE5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other