BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5418559 · Received February 9, 2016

    Report

    Report Number
    2031642-2016-00333
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Report Date
    January 19, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INTERNATIONAL SERVICE TECHNICIAN CONFIRMED THE REPORTED ISSUE. REVIEW OF THE DEVICE DIAGNOSTIC HISTORY INDICATED A BATTERY FAILED REFERENCE FAILURE. NO REPAIRS WERE DONE. THE CUSTOMER DID NOT APPROVE THE PURCHASE ORDER FOR SERVICING THE DEVICE, OR FOR A BATTERY REPLACEMENT.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED AN ISSUE WITH THE BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79302 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1