BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO SERIES C-FLEX ASSY.

    MDR report key: 1854081 · Received September 2, 2010

    Report

    Report Number
    2518422-2010-00092
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K091319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT REPORTED A REMSTAR PRO WITH C-FLEX DEVICE BELONGING TO A CUSTOMER OF THE DME WAS INVOLVED IN A HOUSE FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER REQUESTED THE RETURN OF THE DEVICE FOR EVALUATION AND INVESTIGATION OF THE ALLEGED ISSUE. THE CUSTOMER IS STILL IN POSSESSION OF THE DEVICE AND IS REFUSING TO RETURN THE DEVICE FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE DEVICE IS RETURNED AND THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR PRO SERIES C-FLEX ASSY. VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC. 450P

    Patients

    Seq Age Sex Outcome Treatment
    1 HEATED HUMIDIFIER (B)(4)| POWER SUPPLY PN 1058190L