BEUDAMED
    FDA Adverse Event Death Summary report: N

    U/ADAPT-IT STRT CONCTR 22MM ID X 22MM OD

    MDR report key: 840522 · Received April 19, 2007

    Report

    Report Number
    1423507-2007-00039
    Event Type
    Death
    Date Received
    April 19, 2007
    Date of Event
    March 17, 2007
    Report Date
    April 19, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, AT THIS TIME NO SAMPLE WAS RECEIVED FOR EVAL; AND THEREFORE, WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE REPORTED ISSUES OTHER THAN FROM INFO OBTAINED BY THE END USER. A LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. INFO OBTAINED FROM THE PT'S DAUGHTER STATED THAT THEY KNOWINGLY USED A CRACKED CONNECTOR AND THAT AT SOME TIME DURING THE NIGHT/EARLY MORNING, THE CONNECTOR MUST HAVE FALLEN OUT OF THE CIRCUIT AND THE PT PASSED AWAY. PT HAD BEEN DIAGNOSED WITH ALS JUST OVER A YEAR AGO AT THE TIME OF THE INCIDENT.

    Description of Event or Problem · 1

    END USER CUSTOMER REPORTED THAT THE CONNECTOR WAS CRACKED AND FELL OUT OF THE BIPAP SETUP, AND PT PASSED AWAY REPORTEDLY FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U/ADAPT-IT STRT CONCTR 22MM ID X 22MM OD U/ADAPT-IT STRT CONCTR 22MM ID X 22MM OD BZD CARDINAL HEALTH 004081 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other