BEUDAMED
    FDA Adverse Event Summary report: N

    RESPIRONICS

    MDR report key: 4173250 · Received September 29, 2014

    Report

    Report Number
    4173250
    Date Received
    September 29, 2014
    Date of Event
    January 31, 2013
    Report Date
    September 29, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PM THE OPERATION OF THE NAVRING WAS CHECKED AND FOUND THAT IS WAS SLOW AND NEEDED TO BE REPLACED. PART WAS REPLACED.======================MANUFACTURER RESPONSE FOR VENTILATOR, RESPIRONICS (PER SITE REPORTER).======================THEY JUST GAVE US A PART NUMBER TO REPLACE THE PART. MUCH LATER WE FOUND OUT THAT THERE IS A VOLUNTARY FIELD CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605255 RESPIRONICS VENTILATOR CBK PHILIPS MEDICAL SYSTEMS V60 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *