BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2934382 · Received January 11, 2013

    Report

    Report Number
    8020893-2013-00089
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCO
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THAT SHE HAS SPOKEN TO HER FACILITY MGR IN REGARDS TO THE POWER BROWN OUT AND THEY HAVE COME TO THE CONCLUSION THAT THIS MAY HAVE BEEN AN ISOLATED EVENT IN WHICH THERE WAS A SURGE OR DELAY IN THE POWER BEING PROVIDED THROUGH THE BACK POWER (GENERATOR) SYSTEM. FACILITIES HAS CHECKED THE GENERATOR AND IT IS FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN 840 VENTILATOR EXPERIENCED A POWER LOSS WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO REPRODUCE THE MALFUNCTION. THE UNIT PASSED EXTENDED SELF-TESTING. COVIDIEN WAS NOT AUTHORIZED TO SVC THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19183 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCO 840

    Patients

    Seq Age Sex Outcome Treatment
    1