BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 6157651 · Received December 9, 2016

    Report

    Report Number
    2031642-2016-03339
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 20, 2016
    Report Date
    November 23, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER CONTACTED PRODUCT SUPPORT AND REQUESTED FOR SERVICE REPAIR. THE CUSTOMER REQUESTING TECHNICAL SUPPORT. PER FIELD SERVICE ENGINEER (FSE) PERFORMED COMPLETE PERFORMANCE VERIFICATION (PM) ON THIS UNIT PER CUSTOMER'S REQUEST. VENTILATOR PASSES ALL TESTS AND IS OPERATING PER SPECS. THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM. NO PARTS WERE RETURNED FOR FAILURE INVESTIGATION, THEREFORE THE ROOT CAUSE AT THE COMPONENT LEVEL COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED WITH LOW PRESSURE AND LOW PROXIMAL PRESSURE WHILE PROVIDING THERAPY. THE PATIENT O2 SATURATION FELL TO 40'S. THE CUSTOMER REPORTED THE DEVICE WAS IN USE, BUT THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED WITH LOW PRESSURE AND LOW PROXIMAL PRESSURE WHILE PROVIDING THERAPY. THE PATIENT O2 SATURATION FELL TO 40'S. DURING FOLLOW UP THE REPORTING NURSE CONFIRMED THE PATIENT WAS BAGGED AND HIS SATURATIONS RETURNED TO NORMAL AND HE WAS PLACED ON BIPAP FULLY RECOVERED. SHE ALSO REPORTED THERE WERE NO RELEVANT LABS, TESTS, MEDICAL HISTORY OR CONCOMITANT MEDICATIONS FOR THIS EVENT. THE CUSTOMER REPORTED THE DEVICE WAS IN USE, BUT THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812529 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR