BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS VENT

    MDR report key: 3840814 · Received May 23, 2014

    Report

    Report Number
    MW5036355
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 22, 2014
    Manufacturer
    PHILLIPS
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED THAT MONITOR TECH SAW PT HAD BRADY'D DOWN TO 40S. WHEN STAFF CHECKED PT THE TUBING HAD POPPED OFF VENT. THE VENT WAS NOT ALARMING. RT REPORTS IT HAD BEEN ALARMING EARLIER IN THE SHIFT DURING SUCTION, ETC. PT WAS BAGGED AND RETURNED TO NSR IN 80S. WHILE THE PT WAS OFF VENT AND BEING BAGGED, THE VENT STILL DID NOT ALARM. THIS VENT WAS JUST SERVICED ON (B)(6) 2014. THE RT DIRECTOR WAS CONTACTED THIS AM TO ENSURE VENT IS SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307102 RESPIRONICS VENT VENTILATOR CBK PHILLIPS V1000

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention