BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMSTAR PLUS

    MDR report key: 1351585 · Received March 23, 2009

    Report

    Report Number
    MW5010446
    Event Type
    Death
    Date Received
    March 23, 2009
    Date of Event
    January 10, 2006
    Report Date
    March 23, 2009
    Manufacturer
    RESPIRONICS
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CPAP MACHINE WOULD NOT WORK WHEN PLUGGED IN OUTLET. CPAP MACHINE WOULD ONLY LIGHT UP IN PANEL REMASTER PLUS DOMESTIC MODEL NO. 1005960, TYPE BF CLASS 11 1 PXO, RESULTING WITH FAMILY MEMBERS AND THE PATIENT RETURNING TO THE PLACE OF BUSINESS FOR REPAIR, AND NO RESULTS IN FIXING MACHINE OR A REPLACEMENT -SPARE ONE- UNTIL MACHINE WAS SENT OFF AND FIXED. THIS RESULTED IN PATIENT'S DEATH IN 2006, DUE TO NOT HAVING A SPARE REPLACEMENT OR A REPAIRED CPAP MACHINE TO USE AT TIME OF DEATH, IN WHICH MAY HAD PREVENTED HIS DEATH. DATES OF USE: 2004 -- 2006. DIAGNOSIS OR REASON FOR USE: SLEEP APNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR PLUS CPAP MACHINE/DEVICE BZD RESPIRONICS 1005960

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death