BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PLUS M-SERIES

    MDR report key: 1679455 · Received May 6, 2010

    Report

    Report Number
    2518422-2010-00037
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 6, 2010
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K010263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510 (K)#: K052110.

    Description of Event or Problem · 1

    THE MFR RECEIVED A REPORT THAT THE TOP ENCLOSURE OF A CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE (CPAP) HAD MELTED INTO THE PRINTER CIRCUIT ASSEMBLY (PCA). THERE WAS NO REPORT OF PT HARM OR PROPERTY DAMAGE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR FOR EVAL. A F/U REPORT WILL BE FILED AT THE TIME THE MFR'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR PLUS M-SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC. 200M

    Patients

    Seq Age Sex Outcome Treatment
    1