BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMSTAR PLUS M-SERIES

    MDR report key: 2500916 · Received March 16, 2012

    Report

    Report Number
    2518422-2012-00257
    Event Type
    Death
    Date Received
    March 16, 2012
    Date of Event
    December 24, 2011
    Report Date
    February 16, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K010263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE MFR REC'D A REPORT THAT A HOME-CARE PT HAD DIED SUDDENLY DURING THE NIGHT. THE (B)(4) STATES THE PT WAS BEING TREATED FOR OBSTRUCTIVE SLEEP APNEA (OSA). THE WIFE OF THE DECEASED STATES THE PT HAD A LONG HISTORY OF HEART DISEASE AND SUFFERED WITH MACULAR DEGENERATION AND HEARING LOSS. HOWEVER, SHE CLAIMS SHE IS SUSPICIOUS THAT THE CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE (CPAP) MAY HAVE CAUSED THE DEATH. ACCORDING TO THE (B)(4), THE PT HAD BEEN A LONG TIME CPAP (REMSTAR PLUS M-SERIES) USER APPROX A WEEK BEFORE HIS DEATH, HE HAD REC'D A NEW MASK WHICH IS THE SAME MODEL AS THE ONE THAT HE HAD BEEN USING FOR THE PAST SEVERAL YRS (COMFORTGEL, NASAL MASK, SMALL). THE WIFE STATES THE ONLY COMPLAINT MADE BY THE PT ABOUT THE MASK HAD BEEN THAT HE HAD FOUND IT AWKWARD TO GET ON AND OFF, AND NO CLAIMS WERE MADE OF MALFUNCTIONS. THE WIFE STATES THAT THERE WAS "NO AIR COMING OUT" OF THE DEVICE AND "THERE WAS NO NOISE" FROM THE UNIT. SHE ALSO STATES THAT THE UNIT WAS NOT ALARMING AT THE TIME OF THE DISCOVERY AND COULD HAVE BEEN TURNED OFF BY THE PT. THE (B)(4) STATES THE PT HAD BEEN PRESCRIBED BIPAP THERAPY IN 2009. HOWEVER, HE DID NOT LIKE THE BIPAP AND WENT BACK TO REMSTAR PLUS M AFTER SEVERAL DAYS OF USING BIPAP. DESPITE NUMEROUS REQUESTS, THE UNIT AND THE MASK HAVE YET TO BE RETURNED TO THE MFR FOR EVAL.

    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 78 YR Death COMFORTGEL, SMALL, NASAL MASK, CATALOG #1009041