BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 2801108 · Received October 17, 2012

    Report

    Report Number
    2518422-2012-02133
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K113068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MFR WAS MADE AWARE OF AN ALLEGATION BY AN END USER THAT HE RECEIVED A "BURN" ON HIS ARM AS A RESULT OF PLACING HIS ARM AND HEATED TUBING ASSOCIATED WITH A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE UNDER HIS PILLOW WHILE SLEEPING. THERE WAS NO SERIOUS OR PERMANENT INJURY REPORTED, AND NO MEDICAL INTERVENTION WAS REQUIRED. DESPITE NUMEROUS REQUESTS BY THE MFR, THE DEVICE AND THE ASSOCIATED ACCESSORIES HAVE NOT BEEN RETURNED FOR INVESTIGATION. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE MFR'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 560P

    Patients

    Seq Age Sex Outcome Treatment
    1 HEATED HUMIDIFIER: SN (B)(4), PN 1005792| SYSTEM ONE HEATED TUBE: PN (B)(4)