BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 13766591 · Received March 15, 2022

    Report

    Report Number
    2031642-2022-00669
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    March 3, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE HAD AN OVER VOLTAGE PROTECTION (OVP) FAILURE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM. THE AUTHORIZED SERVICE PROVIDER (ASP) CONFIRMED THAT THE OVP FAILURE IS DISPLAYED. THE ASP REPLACED THE MOTOR CONTROLLER PCBA, AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15679 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776