BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5849803 · Received August 5, 2016

    Report

    Report Number
    2031642-2016-01938
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Report Date
    July 13, 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

    THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE REPORTED ISSUE. IT WAS REPORTED THE BATTERY WAS NOT CHARGED. THE CUSTOMER WAS PROVIDED WITH A PURCHASE ORDER TO REPLACE THE BATTERY. TO DATE THE CUSTOMER HAS NOT APPROVED THE PURCHASE ORDER. FOLLOW UP ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND REPAIR INFORMATION; NO RESPONSE HAS BEEN RECEIVED TO DATE. NO PARTS HAVE BEEN REPLACED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE DEVICE IS NOT WORKING IN BATTERY MODE AND THE BATTERY IS NOT CHARGING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503144 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1