BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4932572 · Received July 22, 2015

    Report

    Report Number
    2031642-2015-01368
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    June 24, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2015. CONCLUSION / ROOT CAUSE: THIS IS THE OLD STYLE DATA ACQUISITION TO MOTOR CONTROLLER CABLE. NO FURTHER FI IS REQUIRED. PLEASE REFERENCE CAPA (B)(4). THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE INTERNATIONAL MANUFACTURER'S SERVICE ENGINEER REPORTED FINDING CODES IN THE DIAGNOSTIC REPORT OF THE DEVICE INDICATING A SPI BUS FAILURE, WHICH IS WHEN THE PCBA ADC REFERENCE FAILS. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE INTERNATIONAL MANUFACTURER'S SERVICE ENGINEER REPORTED FINDING CODES IN THE DIAGNOSTIC REPORT OF THE DEVICE INDICATING A SPI BUS FAILURE, WHICH IS WHEN THE PCBA ADC REFERENCE FAILS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477278 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1