BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5064008 · Received September 9, 2015

    Report

    Report Number
    2031642-2015-01764
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Report Date
    August 12, 2015
    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

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PM (PREVENTATIVE MAINTENANCE) SERVICE, REVIEW OF THE DIAGNOSTIC LOG FOUND ERROR CODES THAT INDICATED A SPI BUS FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595229 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1