BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10857106 · Received November 17, 2020

    Report

    Report Number
    2031642-2020-04188
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Report Date
    October 27, 2020
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6):2021. (B)(6) 2021. THE MANUFACTURER'S TECHNICAL SERVICES (TS) CONFIRMED THE REPORTED ISSUE. THE CUSTOMER WAS WALKED THROUGH RESEATING THE (GROUND) GND SPADE IN FRONT OF THE POWER SUPPLY AND CORRECTED THE GND READING TO THE PROXIMAL PORT CONNECTOR TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. 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: 17NOV2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNIT FAILED ELECTRICAL SAFETY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322704 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1