BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10639673 · Received October 6, 2020

    Report

    Report Number
    2031642-2020-03605
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Report Date
    September 16, 2020
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:11NOV2020 B4:(B)(6)2020 THE CUSTOMER REPORTED THAT THEY REPLACED THE POWER SWITCH OVERLAY AND STILL HAVING THE SAME ISSUE. PRODUCT SUPPORT ADVISED CUSTOMER PRODUCT NUMBER FOR POWER MANAGEMENT (PM) BOARD. SUSPECT PER SERVICE MANUAL REV K (PM) PCB. THE CUSTOMER CANCELLED SERVICE CALL AND DECIDED TO FIX ON THEIR OWN. THEY WILL CONTACT PHILIPS IF THEY NEED HELP IN THE FUTURE. 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: 06OCT2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT HAS A CHECK VENT ALARM LED FAILED. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND REPORTED THAT LED LIGHTS ARE WORKING BUT ARE DIM. PRODUCT SUPPORT ADVISED THE CUSTOMER OF THE SUSPECT POWER SWITCH OVERLAY AND PROVIDED PART ID FOR THE OVERLAY, POWER SWITCH. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097619 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1