BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5188687 · Received October 29, 2015

    Report

    Report Number
    2031642-2015-02206
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Report Date
    October 5, 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

    EVENT DATE: (B)(6) 2015. RECEIVED BY M,FRDATE: 04/12/2016. CONCLUSION / ROOT CAUSE: THE BLOWER ASSEMBLY PASSED ALL TESTING. A HIGH BLOWER TEMPERATURE ALARM (1122 ERROR CODE) COULD NOT BE DUPLICATED. THERE WERE NO FAULTS FOUND WITH THE BLOWER ASSEMBLY. 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 THE DEVICE ALARMED DUE TO A BLOWER TEMPERATURE HIGH REFERENCE FAILURE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720198 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR