BEUDAMED
    FDA Adverse Event Death Summary report: N

    S9 AUTOSET - AUSTRALIA

    MDR report key: 2158373 · Received July 6, 2011

    Report

    Report Number
    3004604967-2011-00036
    Event Type
    Death
    Date Received
    July 6, 2011
    Date of Event
    January 21, 2011
    Report Date
    June 30, 2011
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K091947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PT WAS AN EXPERIENCED CPAP USER INVOLVED IN A RESMED MASK USABILITY TRIAL WITH AN S9 APAP DEVICE. DURING A ROUTINE APPOINTMENT ON (B)(6) 2011, THE CLINICAL CONSULTANT OBSERVED WHAT APPEARED TO BE A DEGRADATION IN THE HEALTH OF THE PT. THE CONSULTANT THEN REFERRED THE PT TO AN AMBULANCE THAT TRANSPORTED HER TO THE HOSPITAL. THE PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 COMPLAINING OF SHORTNESS OF BREATH AND CHEST PAIN, AND WAS DIAGNOSED WITH A PNEUMOTHORAX. SHE ALSO HAD UNDERLYING BULLOUS EMPHYSEMA, AND A DEVELOPING PULMONARY FIBROSIS WITH PREDOMINANT INVOLVEMENT OF THE LEFT LUNG. THIS PT HAD A PROGRESSIVE DECLINE IN HER RESPIRATORY FUNCTION OVER THE COURSE OF HER HOSPITAL ADMISSION. THE PT PASSED AWAY ON (B)(6) 2011. A CLINICAL OPINION WAS OBTAINED FROM A DOCTOR AT THE HOSPITAL: "IT IS MY OPINION THAT THIS LADY'S INVOLVEMENT IN THE TRIAL DID NOT INFLUENCE OR CONTRIBUTE TO HER ADVERSE EVENT (PNEUMOTHORAX). HER TREATMENT DECISION TO BE ON CPAP WAS MADE WELL BEFORE THE TRIAL AND THE VARIOUS MASKS ARE UNLIKELY TO HAVE BEEN A RELEVANT FACTOR. HER CPAP TREATMENT MAY HAVE BEEN CONTRIBUTORY BUT SETTINGS WERE AS PER HER PRE-TRIAL INTERVENTION AND AS SUCH THE FACTORS CHANGE IN THE TRIAL ARE NOT THOUGHT CONTRIBUTORY." THE S9 APAP DEVICE WAS RETURNED AND EVALUATED BY THE MANUFACTURER. THERE WERE NO ERRORS OR MALFUNCTIONS OBSERVED WITH THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED LTD THAT A PT DIED FOLLOWING PARTICIPATION IN RESMED MASK USABILITY TRIAL. DURING THE TRIAL, THE PT WAS USING AN S9 APAP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S9 AUTOSET - AUSTRALIA BZD RESMED LTD 36385

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death EASYLIFE MASK| MIRAGE FX MASK