BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIELITE DELUXE

    MDR report key: 2157911 · Received June 28, 2011

    Report

    Report Number
    2243193-2011-00005
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 28, 2011
    Manufacturer
    RESPIRONICS NEW JERSEY INC.
    Product Code
    CAF
    PMA / PMN Number
    K060404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MONITORING FOR SIMILAR FAILURES. NO OTHER REPORTS OF THIS TYPE AT PRESENT.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS UNIT EXPLODED AND DAMAGED HER CARPET. NO DEATH OR SERIOUS INJURY REPORTED. PICTURE OF DEVICE SHOWED THERMAL DAMAGE, BUT THE DEVICE IS INTACT WITH NO EVIDENCE OF EXPLOSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIELITE DELUXE MINIELITE CAF RESPIRONICS NEW JERSEY INC. RDD483

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN