BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8883340 · Received August 12, 2019

    Report

    Report Number
    2031642-2019-05815
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Report Date
    November 29, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2017. DATE OF REPORT: 12AUG2019. THE FIELD SERVICE ENGINEER REPLACED THE FRONT BEZEL TO ADDRESS THE REPORTED ISSUE. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER A REQUEST FROM THE FDA ON MARCH 1, 2019 TO REVIEW COMPLAINTS FROM 29 NOV 2017 TO 29 NOV 2018. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NAVIGATION-RING DIDN'T WORK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680273 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1