BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10890977 · Received November 24, 2020

    Report

    Report Number
    2031642-2020-04229
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Report Date
    October 28, 2020
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:18FEB2021. B4:19FEB2021. H11:G5:K102985 H10: THE ALARM WAS CLARIFIED TO BE LOW TIDAL VOLUME. THE CUSTOMER DECLINED SUPPORT AND REPAIR. NO FURTHER INFORMATION IS AVAILABLE. . SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 23NOV2020.

    Description of Event or Problem · 1

    AN ALARM WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354634 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1