BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 1386553 · Received April 30, 2009

    Report

    Report Number
    MW5011102
    Event Type
    Death
    Date Received
    April 30, 2009
    Date of Event
    December 8, 2007
    Report Date
    April 29, 2009
    Manufacturer
    RESPIRONICS
    Product Code
    NPF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IN 2007, A MALE PT. THEY CHOSE TO PUT AN APNEA ON HIM - THEY WANTED IT CONTINUED AT HOME. THIS MACHINE WAS TOTALLY UNRELIABLE GOING OFF WHEN SHOULDN'T. THEY STATED IN THE PAPER "THE CHIP WAS NEVER ON". SIMPLY NOT TRUE. JUST IN THIS TOWN WE HAVE 20 PEOPLE WITH THE SAME EXISTING PROBLEMS - WE'VE PUT IN ON THE INTERNET AND YOU WOULDN'T BELIEVE THE RESPONSE. WE ARE GATHERING MUCH INFORMATION - THIS AGENCY HAS EVEN IGNORED THE CORONERS REPORT OF SIDS AND EVEN HE SAID "THESE MACHINES ARE UNRELIABLE". THEY ARE CHARGING MY SON AND DAUGHTER-IN-LAW WITH NEGLECT. DOSE OR AMOUNT: USE AS NEEDED. FREQUENCY: 24/7. DATES OF USE: 2007. DIAGNOSIS: SUPPOSED HIGH RISK BREATHING PROBLEM. SECOND MONITOR THE MONTH PRIOR. TWO WEEKS PRIOR, HOSPITAL HAS OWN APNEA MACHINE USED TILL NINE DAYS LATER. SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRONICS APNEA MONITOR NPF RESPIRONICS #2 SMART MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Death| O