BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 5064002 · Received September 9, 2015

    Report

    Report Number
    2031642-2015-01772
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    August 30, 2015
    Report Date
    September 1, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING UPGRADED TO SERIOUS INJURY, THE DEVICE DISPLAYED A ¿VENT INOP¿ ERROR MESSAGE, BECAME INOPERATIVE AND STOPPED PROVIDING THERAPY DURING TRANSPORT. THE PATIENT WAS PLACED ON A NON-REBREATHER UNTIL A SECOND VENTILATOR WAS READY FOR USE. MEDWATCH# (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER EVALUATED THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING TRANSPORT, THE DEVICE WENT INTO VENT INOP, MACHINE AND PROXIMAL PRESSURE SENSORS FAILED. VENT INOP IS A HIGH PRIORITY CONDITION THAT PRECLUDES SAFE OPERATION OF THE VENTILATOR. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING TRANSPORT THE DEVICE WENT VENT INOP, MACHINE AND PROXIMAL PRESSURE SENSORS FAILED. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594958 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR