BEUDAMED
    FDA Adverse Event Death Summary report: N

    V60 VENTILATOR

    MDR report key: 6135849 · Received November 30, 2016

    Report

    Report Number
    2031642-2016-03261
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE BIOMEDICAL ENGINEER HAS RAN THE UNIT AND CANNOT DUPLICATE THE ISSUE. NO PROBLEM FOUND WITH THE DEVICE THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM PATIENT INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE ALARM VOLUME WAS SET AT FOUR. THE PATIENT WAS NOT CONNECTED TO ANY REMOTE ALARMS OR SPO2 MONITOR/ALARM AND THE CUSTOMER COULD NOT REPORT HOW FAR AWAY THE PATIENT WAS FROM THE NURSING STATION. RESPIRATORY THERAPIST MAKE ROUNDS ON PATIENTS EVERY FOUR HOURS WHEN A PATIENT IS ON NON-INVASIVE VENTILATION (NIV). THE DEVICE RECORD WAS REVIEWED AND THE ALARM VOLUME SETTING WAS CONFIRMED AT FOUR. THERE WERE NO HARD WARE ISSUES NOTED. ALARM SILENCE ARE NOT CAPTURED ON THE DEVICE RECORD, HOWEVER THERE WERE SEVERAL ALARMS RECORDED AND IT IS POSSIBLE THAT THE TWO MINUTE ALARM AUDIBLE ALARM SILENCE WAS ACTIVE. NO FURTHER INFORMATION WILL BE AVAILABLE.

    Description of Event or Problem · 1

    THE RESIDENT STATED THE PATIENT CIRCUIT WAS DISCONNECTED AND THE ALARM WAS NOT AUDIBLE. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    A RESIDENT REPORTED THE ALARM ON THE VENTILATOR WAS NOT AUDIBLE THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784995 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1