BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3914193 · Received July 3, 2014

    Report

    Report Number
    2031642-2014-00608
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    REPIRONICS CALIFORNIA INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFR DATE: 09/15/2014. THE POWER MANAGEMENT (PM) PCBA (B)(4) AND POWER MANAGEMENT (PM) PCBA (B)(4) WAS TESTED AND NO FAILURES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND WAS TURNING ON AND OFF. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE FACILITY BIOMEDICAL ENGINEER REPORTED THE POWER MANAGEMENT PCB BOARD AND POWER SUPPLY WAS REPLACED HOWEVER THE PROBLEM WAS NOT CORRECTED, AND MANUFACTURERS FIELD SERVICE WAS REQUESTED FOR REPAIR. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE THE REPORTED PROBLEM. THE FSE REPORTED FINDING LOOSE COMPONENTS AND SCREWS INSIDE THE VENT FROM THE PREVIOUS SERVICE BY THE BIOMEDICAL ENGINEER. DUE TO THE PREVIOUS SERVICE AND SERVICE FINDINGS OF THE BIOMED, THE FSE INITIALLY REPLACED THE PM BOARD AND POWER SUPPLY AGAIN, BUT THE UNIT WAS STILL TURNING ON AND THEN OFF. DUE TO THE INTERMITTENT NATURE OF THE REPORTED PROBLEM, AND SERVICE INDUCED ISSUES DURING THE PREVIOUS BIOMED SERVICE, THE FSE REPLACED THE MOTOR CONTROLLER, POWER MANAGEMENT AND CPU PCB BOARDS, AND POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391039 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT REPIRONICS CALIFORNIA INC V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1