BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10693586 · Received October 16, 2020

    Report

    Report Number
    2031642-2020-03748
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Report Date
    September 22, 2020
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:25JAN2021 AND B4:25JAN2021 H3: NOT RETURNED TO MANUFACTURER. 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: 16OCT2020.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED TECHNICAL SUPPORT (TS) STATING THAT THE UNIT HAD A PRESSURE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE REPORTED ISSUE WAS FOUND DURING SETUP. NO DELAY OR INTERVENTION WAS REPORTED. THE CUSTOMER, THE BIOMED, EVALUATED THE UNIT AND FOUND THE DATA ACQUISITION (DAQ) BOARD WAS LOOSE. THE CUSTOMER RESEATED THE UNIT'S DAQ BOARD TO RESOLVE THE REPORTED ISSUE. THE UNIT WAS TESTED AND PASSED. THE UNIT RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159040 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1