BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4895740 · Received July 7, 2015

    Report

    Report Number
    2031642-2015-01228
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Report Date
    June 11, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION / ROOT CAUSE: THIS POWER SUPPLY WAS TESTED WITH NO FAILURES 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 DEVICE WOULD NOT POWER ON. NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WOULD NOT POWER ON. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440018 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1