BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 7441302 · Received April 18, 2018

    Report

    Report Number
    2031642-2018-00817
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Report Date
    March 21, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 09/07/2018. DATE RECEIVED BY MANUFACTURER: 05/07/2018. (UDI); (METHOD, RESULTS, CONCLUSION CODES); PHILIP'S SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE BATTERY. THE VENTILATOR PASSED ALL TESTING AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WILL NOT OPERATE ON BATTERY. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283206 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1