BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6070631 · Received November 1, 2016

    Report

    Report Number
    2031642-2016-02949
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    October 4, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACTED CUSTOMER REQUESTING FOR PATIENT INFORMATION AND EVENT DATE, BUT NO RESPONSE RECEIVED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ROOT CAUSE: FAILURE ANALYSIS ON THE RETURNED CPU BOARD FOUND THAT THE BUZZER LS1 OF THE CPU BOARD HAD FAILED DUE TO A COLD SOLDER JOINT WHICH TRIGGERED ERROR CODE 1104. REPLACING LS1 RESOLVED THE PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED WITH BACK-UP ALARM TEST FAILED OCCURRENCE. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON PATIENT, BUT THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722600 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1