BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NELLCOR BEDSIDE RESPIRATORY PATIENT MONI

    MDR report key: 11259881 · Received January 29, 2021

    Report

    Report Number
    MW5099099
    Event Type
    Injury
    Date Received
    January 29, 2021
    Date of Event
    January 21, 2021
    Report Date
    January 27, 2021
    Manufacturer
    COVIDIEN
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S BEDSIDE OXYGEN SATURATION MONITOR CHECKS WERE INDICATING 100% EVEN THOUGH HE DID NOT LOOK WELL, HE WAS SHORT OF BREATH AND HYPOXIC. THE RESIDENT USED HIS PORTABLE O2 SAT MONITOR THAT HE PURCHASED ON (B)(6) AND IT SHOWED PATIENT'S O2 SAT IN THE LOW 8)S. ABG'S WERE PERFORMED AND SHOWED O2 SAT AT 68. THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146011 NELLCOR BEDSIDE RESPIRATORY PATIENT MONI OXIMETER DQA COVIDIEN PM1000N

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening