BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5635127 · Received May 5, 2016

    Report

    Report Number
    2031642-2016-01111
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Report Date
    April 11, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE CUSTOMER DID NOT APPROVE THE PURCHASE ORDER TO REPLACE THE BATTERY. THE SERVICE TECHNICIAN ALSO REPORTED THE ONLY ISSUE WITH THE DEVICE WAS THE FAULTY BATTERY.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE DEVICE BATTERY DOES NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290477 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1