BEUDAMED
    FDA Adverse Event Other Summary report: N

    REMSTAR PRO INTERNATIONAL

    MDR report key: 2163593 · Received June 2, 2011

    Report

    Report Number
    2518422-2011-00055
    Event Type
    Other
    Date Received
    June 2, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 5, 2011
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K091319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALLEGED THE DEVICE HAD AN ODOR THAT CAUSED HIS INFLAMMATORY CONDITION TO RETURN. THERE WAS NO REPORT OF HOSPITALIZATION ASSOCIATED WITH THE ALLEGED EVENT. THERE WAS NO MEDICAL EVIDENCE PROVIDED IN THE FORM OF PT RECORDS OR RESULTS OF A TRANSBRONCHIAL LUNG BIOPSY TO CONFIRM THE CUSTOMER'S ALLEGATION. THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. AN INVESTIGATION OF THE ALLEGED INCIDENT IS BEING CONDUCTED. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS CONCLUDED.

    Description of Event or Problem · 1

    A CUSTOMER ALLEGED THAT HE DEVELOPED SARCOIDOSIS, AN INFLAMMATORY CONDITION OF UNK CAUSE, AFTER USING A REMSTAR PRO CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE. THE CUSTOMER REPORTED BEING TREATED WITH CORTISONE AND HAVING HIS SYMPTOMS SUBSIDE; BUT HIS SYMPTOMS RETURNED WHEN HE ATTEMPTED TO USE THE CPAP DEVICE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR PRO INTERNATIONAL VENTILATOR, NON-CONTINUOUS, RESPIRATOR BZD RESPIRONICS, INC. 451P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HEATED HUMIDIFIER, SN (B)(4)