BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM

    MDR report key: 8805550 · Received July 18, 2019

    Report

    Report Number
    2031642-2019-04819
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    May 14, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNS
    PMA / PMN Number
    K053168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT 18JUL2019. THE DEVICE WAS EVALUATED BY A PHILIPS FSE DURING SCHEDULE PM SERVICE THE REPORTED ISSUE WAS CONFIRMED. THE PARTS ARE NOT AVAILABLE FOR ORDER, UNABLE TO CORRECT REPORTED PROBLEM; CUSTOMER ADVISED TO REMOVE THE UNIT FROM SERVICE.

    Description of Event or Problem · 1

    DURING SERVICE FSE WAS PERFORMING PREVENTATIVE MAINTENANCE (PM) AND THE UNIT REQUIRED A NEW CASING AND FAILED PRESSURE TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594927 BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS CALIFORNIA, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1