BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 4093584 · Received September 3, 2014

    Report

    Report Number
    8020893-2014-02115
    Event Type
    Injury
    Date Received
    September 3, 2014
    Report Date
    August 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    COVIDIEN CUSTOMER SUPPORT ENGINEER ( CSE) INSPECTED THE DEVICE AND REPLACED THE PSOL ASSEMBLY. THE VENTILATOR PASSED ALL CALIBRATIONS, EXTENDED SELF-TEST, SHORT SELF-TEST AND PERFORMANCE VERIFICATION TEST (PVT).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT THE PB980 VENTILATOR ALARMED AND BECAME INOPERATIVE WHILE IN USE ON A PATIENT. ACCORDING TO THE REPORT, THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY BAGGED VIA AMBU BAG. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537214 980 VENTILATOR VENTILATOR, CONTINUOUS USE, FACILITY CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention