BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PB980

    MDR report key: 4123679 · Received September 26, 2014

    Report

    Report Number
    8020893-2014-02266
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER ( CSE) INSPECTED THE DEVICE AND FOUND NO PROBLEM WITH THE VENTILATOR. THE CSE RAN THE VENTILATOR FOR 24 HOURS ON TEST LUNG AND COULD NOT DUPLICATE ANY PROBLEM. THE UNIT PASSED EXTENDED SELF-TEST, SHOT SELF-TEST AND ELECTRICAL SAFETY TEST.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING USE, THE PB980 VENTILATOR WAS ALARMING HIGH PRESSURE. IT WAS REPORTED THAT THE RESPIRATORY RATE WAS SET AT 14 HOWEVER, THE PATIENT'S RESPIRATORY RATE REGISTERED 130 BREATHS PER MINUTE. THE PATIENT WAS PLACED ON AN 840 VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600288 PB980 VENTILATOR, CONTINUOUS USE, FACILITY USE CBK COVIDIEN PB980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention