BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3913124 · Received July 3, 2014

    Report

    Report Number
    2031642-2014-00606
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    REPIRONICS CALIFORNIA INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED DATE: 09/15/2014. CONCLUSION / ROOT CAUSE: THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), MOTOR CONTROLLER (MC) PCB AND CENTRAL PROCESSING UNIT (CPU) PCBA 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 DUE TO A 12 VOLT SUPPLY FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. A 12 VOLT SUPPLY FAILURE MAY RESULT IN A VENT INOP CONDITION DURING NORMAL VENTILATION MODE OPERATION. A VENT INOP CONDITION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. THE FSE REPLACED THE CPU, POWER MANAGEMENT AND MOTOR CONTROLLER PCB BOARDS TO CORRECT THE REPORTED PROBLEM. THE DEVICE PASSED ALL MANUFACTURER REQUIRED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390314 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT REPIRONICS CALIFORNIA INC V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1