BEUDAMED
    FDA Adverse Event Death Summary report: N

    PB540 VENTILATOR

    MDR report key: 4153038 · Received October 8, 2014

    Report

    Report Number
    8020893-2014-02324
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    December 26, 2012
    Report Date
    September 17, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR SERIAL NUMBER IS UNKNOWN, AND THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE REPORTED EVENT: THE REPORTING PUBLIC HEALTH PHYSICIAN INDICATED THAT THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE IS NO EVIDENCE THAT THE PATIENT DEATH WAS DEVICE-RELATED. THE REPORTING PHYSICIAN MADE IT CLEAR THAT THE PURPOSE OF HIS CALL ON (B)(6) 204 WAS TO OBTAIN INFORMATION FROM COVIDIEN TECHNICAL SUPPORT REGARDING THE CHARACTERISTICS AND FUNCTIONALITY OF THE PB540 VENTILATOR. THE DEVICE SERIAL NUMBER IS UNAVAILABLE AND THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, COVIDIEN RECEIVED INFORMATION FROM THE (B)(6) DEPARTMENT OF PUBLIC HEALTH REGARDING THE DEATH OF A PATIENT ON A 540 VENTILATOR THAT WAS LEFT IN THE STAND-BY MODE. THE PATIENT WAS NOT VENTILATED WHILE THE VENTILATOR WAS IN STAND-BY MODE AND HAD A CARDIAC ARREST RESULTING IN DEATH. THE PATIENT WAS AT A SKILLED NURSING FACILITY AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631618 PB540 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 4097100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death