BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 7125088 · Received December 18, 2017

    Report

    Report Number
    2031642-2017-03852
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    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
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PER BIOMED, HE REPLACED THE USER INTERFACE BOARD AND CABLE TO ADDRESS THE REPORTED ISSUE. THE BIOMED DID NOTICE A CONNECTION THAT CAME LOOSE AND I RE-ATTACHED DURING REPLACEMENT OF THE USER INTERFACE BOARD. THE DEVICE PASSED ALL CHECKS WITH NO FURTHER ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY CHARGING LED IS NOT LIT. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906774 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1