BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 7095905 · Received December 7, 2017

    Report

    Report Number
    2031642-2017-03750
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Report Date
    October 24, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MMI PRINTED CIRCUIT BOARD ASSEMBLY WAS RETURNED TO THE MANUFACTURER FOR EVALUATION FROM A FACILITY'S ALLEGATION OF A VENTILATOR THAT FAILED A PRIMARY AUDIBLE ALARM TEST. THE MANUFACTURER'S TECHNICIAN CONFIRMED THAT THE COMPONENT, WHEN UTILIZED WITH THE TEST VENTILATOR, WOULD NOT ALLOW VOLUME TO BE CHANGED. THE MANUFACTURER'S TECHNICIAN FIRST OBSERVED THAT THE VOLUME COULD NOT BE CHANGED WHEN UTILIZED WITH THE TEST VENTILATOR. THEN, THE TECHNICIAN USED THE FI TEST OSCILLISCOPE TO TRACE THE FAILURE TO THE NPN SWITCHING TRANSISTOR Q1. IT WAS FOUND THAT THIS OUTPUT THIS TRANSISTOR WAS SHORTED ACROSS ALL PINS WITH 10.1 OHMS OF RESISTANCE. THE ROOT CAUSE WAS A SHORTED NPN SWITCHING TRANSISTOR Q1. REPLACING THE Q1 CORRECTED THE FAILURE WITH THIS MMI BOARD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A VENTILATOR WITH A FAILED AUDIBLE ALARM TEST. NO PATIENT INVOLVEMENT / HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876173 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1