BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIELITE COMPRESSOR NEBULIZER SYSTEM BATTERY

    MDR report key: 2080181 · Received April 7, 2011

    Report

    Report Number
    2243193-2011-00001
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 4, 2011
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Product Code
    BTI
    PMA / PMN Number
    K060404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY WAS DISCARDED IN ERROR BY (B)(4). (B)(4) TESTING ON FILE FOR THIS MODEL PRODUCT. NO HISTORY OF SIMILAR INCIDENTS. RESPIRONICS WILL CONTINUE TO MONITOR FOR THIS ISSUE.

    Description of Event or Problem · 1

    (B)(4) REPORTED THAT SMOKE WAS DETECTED COMING FROM A PACKAGE THEY WERE PREPARING FOR DELIVERY FROM ONE OF THEIR TRUCKS. THERE WAS NO POWER BEING SUPPLIED TO THE UNIT AND THE BATTERY WAS NOT INSTALLED IN THE UNIT AT THE TIME OF THE ALLEGED INCIDENT. THIS UNIT WAS NOT IN USE AT THE TIME OF THE ALLEGED INCIDENT AND THE BATTERY ASSOCIATED WITH THE PRODUCT WITH THE ALLEGED ISSUE WAS ACCIDENTALLY DISCARDED BY (B)(4) AFTER BEING EXPLICITLY TOLD TO SEND IT TO RESPIRONICS FOR EVALUATION. THE COMPRESSOR SHOWED NO SIGN OF DAMAGE, BUT DID HAVE AN ODOR. THE UNITS CONTAINED IN THE SAME CASE CARTON AS THE SUSPECT UNIT WERE RETURNED AND EVALUATED WITH NO ISSUES FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIELITE COMPRESSOR NEBULIZER SYSTEM BATTERY COMPRESSOR NEBULIZER SYSTEM BTI RESPIRONICS NEW JERSEY, INC. RDD483 111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA