BEUDAMED
    FDA Adverse Event Death Summary report: N

    V60 VENTILATOR

    MDR report key: 7296542 · Received February 26, 2018

    Report

    Report Number
    2032640-2018-00006
    Event Type
    Death
    Date Received
    February 26, 2018
    Date of Event
    February 5, 2018
    Report Date
    February 6, 2018
    Manufacturer
    PHILIPS HEALTHCARE / INNER COOL
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER WAS NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    SEE REPORT #2031642-2018-00881.

    Description of Event or Problem · 1

    A DETECTIVE REPORTED THAT HE SUSPECTED THE V60 VENTILATOR HAD BEEN TAMPERED WITH BY A PATIENT¿S FAMILY CAUSING THE PATIENT¿S DEATH. THE PATIENT CIRCUIT HAD BEEN TAKEN OFF AND A DOLLAR BILL AND A SYRINGE WAS FOUND AT THE GAS OUTLET PORT. THE OUTLET WAS NOT COMPLETELY OCCLUDED. MORE INFORMATION HAS BEEN REQUESTED. AN (B)(6) FEMALE PATIENT WAS PLACED ON A V60 VENTILATOR OCCASIONALLY TO INCREASE OXYGEN SATURATION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140510 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT PHILIPS HEALTHCARE / INNER COOL V60

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death