BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8705150 · Received June 17, 2019

    Report

    Report Number
    2031642-2019-03886
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Report Date
    June 6, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE REC'D BY MFR: 02JUL2019. DATE OF REPORT: 07AUG2019. THE TECHNICIAN CONFIRMED THE CUSTOMER ALLEGATION AND RECOMMENDED REPLACEMENT OF THE POWER SUPPLY TO ADDRESS THIS ISSUE. THE TECHNICIAN REPLACED THE POWER SUPPLY TO ADDRESS THIS ISSUE. 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 · 0

    DATE RECEIVED BY MANUFACTURER: 03OCT2019. DATE OF REPORT: 03OCT2019. NO FAULT FOUND. UNABLE TO REPLICATE REPORTED FAILURE FOR EITHER CENTRAL PROCESSING UNIT OR POWER MANAGEMENT BOARDS. 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) 2019. DATE OF REPORT: 06/17/2019. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    AC POWER LOSS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497059 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1