BEUDAMED
    FDA Adverse Event Death Summary report: N

    BCI

    MDR report key: 348192 · Received August 22, 2001

    Report

    Report Number
    348192
    Event Type
    Death
    Date Received
    August 22, 2001
    Date of Event
    July 31, 2001
    Report Date
    August 9, 2001
    Manufacturer
    SIMMS BCI
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT NON VENTILATED AND ON A PULSE OXIMETER. PT CHECKED BY NURSE AT 1900 & 2300. AT 0050 LPN FOUND PT UNRESPONSIVE, PULSELESS, APNEIC. LPN REPORTS THE OXIMETER FINGER PROBE WAS ATTACHED TO THE PT'S FINGER AND PROBE ATTACHED TO THE OXIMETER. OXIMETER WAS NOT ALARMING AND THE DISPLAY PANEL HAD RED DOTTED LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38310 BCI PULSE OXIMETER MONITOR DQA SIMMS BCI 71200A1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death