BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP VISION VENTILATORY SUPPORT

    MDR report key: 2928369 · Received January 10, 2013

    Report

    Report Number
    2928369
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    May 27, 2012
    Report Date
    January 10, 2013
    Manufacturer
    RESPIRONIC, INC.
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BIPAP SYSTEM EXPERIENCED COMPLETE POWER FAILURE WHILE ON A PATIENT. PATIENT WAS ACUTELY DESATURATED AND BECAME MORE TACHYPNEIC, REQUIRING IMMEDIATE ACTION TO REVERSE EFFECTS OF DEVICE FAILURE. PATIENT WAS TAKEN OFF OF DEVICE WHICH WAS REPLACED BY ANOTHER UNIT.======================DISTRIBUTER RESPONSE FOR BIPAP SYSTEM, VISION BIPAP SYSTEM (PER SITE REPORTER).======================"THE UNIT WAS INSPECTED FOR ELECTRICAL, MECHANICAL SAFETY AND PROPER OPERATION ACCORDING TO UNIVERSAL HOSPITAL SERVICES (UHS) PROCEDURE AIK AND WAS FOUND ACCEPTABLE. THIS INCLUDES A TEST OF ALL ALARMS, WHERE APPLICABLE. THIS UNIT HAS BEEN CLEANED ACCORDING TO UHS STANDARDS AND FOUND TO BE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15276 BIPAP VISION VENTILATORY SUPPORT VENTILATOR, CONTINUOUS MNT RESPIRONIC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *