BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR M SERIES

    MDR report key: 1551285 · Received November 25, 2009

    Report

    Report Number
    2518422-2009-00074
    Event Type
    Malfunction
    Date Received
    November 25, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 28, 2009
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K010263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510K: K052110.

    Description of Event or Problem · 1

    A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE FAILURE REPORTEDLY RESULTED IN A THERMAL VOID IN THE DEVICE'S TOP ENCLOSURE. NO PATIENT HARM OR INJURY OCCURRED AS A RESULT OF THE DEVICE FAILURE. THE DEVICE ASSOCIATED WITH THE REPORTED PRODUCT PROBLEM HAS BEEN RETURNED AND AN INVESTIGATION OF THE REPORTED EVENT HAS BEEN INITIATED. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR M SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC. 101M

    Patients

    Seq Age Sex Outcome Treatment
    1