BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 9597322 · Received January 16, 2020

    Report

    Report Number
    2031642-2020-00202
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Report Date
    January 3, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 01/16/2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD A TOUCHSCREEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62473 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown