BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11957886 · Received June 8, 2021

    Report

    Report Number
    2031642-2021-03978
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 18, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNS
    PMA / PMN Number
    K053168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K053168. B4:10JUL2021. THE SERVICE ENGINEER (SE) COULD NOT CONFIRM THE FAILURE. THE CUSTOMER DECLINED REPAIR OF THE UNIT. NO PARTS WERE REPLACED. THE CUSTOMER DECLINED REPAIR.

    Additional Manufacturer Narrative · 1

    EVENT: (B)(6) 2021. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT CANNOT BE USED. THE DEVICE WAS NOT IN CLINICAL USE. NO PATIENT OR USER HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859259 RESPIRONICS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS CALIFORNIA, LLC BIPAP FOCUS SYSTEM, INT'L, RENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1