BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4090256 · Received September 15, 2014

    Report

    Report Number
    2031642-2014-01038
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 18, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2014. RECEIVED BY MFR DATE: 10/23/2014. CONCLUSION / ROOT CAUSE: THE DATA ACQUISITION 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 SHUT OFF DURING NORMAL VENTILATION OPERATION. THE CUSTOMER REPORTED THE UNIT WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE REPORTED REVIEW OF THE DEVICE DIAGNOSTIC HISTORY NOTED A DATA ACQUISITION PCBA ADC FAILURE WHICH MAY RESULT IN A VENT INOP OCCURRENCE. A VENT INOP CONDITION DURING OPERATION 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 FSE REPLACED THE DATA ACQUISITION PCB BOARD TO ADDRESS THE FINDINGS AND REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568674 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1