BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 9717937 · Received February 17, 2020

    Report

    Report Number
    2031642-2020-00530
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Report Date
    January 28, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 17FEB2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OVP (OVER VOLTAGE PROTECTION) CIRCUIT FAILED. THE SERVICE TECHNICIAN CONFIRMED AN ERROR CODE WAS PRESENT IN THE DIAGNOSTIC LOG WHICH INDICATES OVP CIRCUIT FAILURE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED, THEREFORE, THERE WAS NO PATIENT OR USER HARM REPORTED. THE SERVICE TECHNICIAN REPLACED THE PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) MC (MOTOR CONTROLLER) TO RESOLVE THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182038 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1