BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5754483 · Received June 28, 2016

    Report

    Report Number
    2031642-2016-01592
    Event Type
    Malfunction
    Date Received
    June 28, 2016
    Report Date
    June 6, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: IT WAS REPORTED BETWEEN (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: CENTRAL PROCESS UNIT CPU PCBA (CENTRAL PROCESS UNIT PRINTED CIRCUIT BOARD) WAS REPLACED AS A PRECAUTION. CPU BOARD WAS RECEIVED AT THE V60 VENT MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY SIGNS OF DAMAGE OR CONTAMINATION. CPU BOARD WAS INSTALLED IN THE TEST VENTILATOR IN AN ATTEMPT TO DUPLICATE THE REPORTED PROBLEM. TESTING OF THE VENTILATOR DID NOT IDENTIFY ANY ANOMALIES OR ERRORS. THE SETTINGS STAYED STABLE DURING THE RUN. RESOLUTION AND DISPOSITION: NO FAILURES WERE IDENTIFIED. THE ROOT CAUSE FOR THE CUSTOMER'S REPORTED EXPERIENCE OF SETTING AUTOMATICALLY WENT BACK TO THOSE BEFORE CHANGE COULD NOT BE IDENTIFIED. TESTING OF THE CUSTOMER'S V60 VENT AT THE INTERNATIONAL SERVICE CENTER DID NOT DUPLICATE THE ISSUE, ALSO TESTING OF THE CPU BOARD REPLACED BY INTERNATIONAL SERVICE TECHNICIAN, WHICH UNDERWENT TESTING USING THE MANUFACTURER'S TEST VENTILATOR, DID NOT IDENTIFY ANY ANOMALIES.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE DEVICE SETTING WAS MANUALLY CHANGED (FROM CPAP TO S/T, FROM FIO2 60% TO 100%), BUT AFTER A WHILE THE SETTING AUTOMATICALLY WENT BACK TO THOSE BEFORE CHANGE (FROM S/T TO CPAP AND FROM FIO2 100% TO 60%). THE UNIT WAS BEING USED ON A PATIENT AT THE TIME THE REPORTED ISSUE OCCURRED. HOWEVER, THERE WAS NO ADVERSE PATIENT EFFECT.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE DEVICE SETTING WAS MANUALLY CHANGED (FROM CPAP TO S/T, FROM FIO2 60% TO 100%), BUT AFTER A WHILE THE SETTING AUTOMATICALLY WENT BACK TO THOSE BEFORE CHANGE (FROM S/T TO CPAP AND FROM FIO2 100% TO 60%). THE UNIT WAS BEING USED ON A PATIENT AT THE TIME THE REPORTED ISSUE OCCURRED. HOWEVER, THERE WAS NO ADVERSE PATIENT EFFECT. THE V60 IN QUESTION WAS REPLACED FOR A SECOND ONE TO CONTINUE PATIENT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408565 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1