BEUDAMED
    FDA Adverse Event Death Summary report: N

    840 VENTILATOR

    MDR report key: 4020021 · Received July 28, 2014

    Report

    Report Number
    8020893-2014-01880
    Event Type
    Death
    Date Received
    July 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 14, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 840 VENTILATOR ALONG WITH THE 806 COMPRESSOR WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION INDICATED THAT IT WAS OPERATED IN AN EXTREMELY DUSTY ENVIRONMENT. EXTERNALLY IT WAS VERY DUSTY AND DIRTY, AND IN VERY POOR CONDITION. THERE WAS NO INFORMATION AVAILABLE, FROM THE CUSTOMER SITE, ON THE ALARM SETTINGS OR ALARM LOGS. WHILE THERE WERE SEVERAL ISSUES FOUND ON THIS VENTILATOR AND COMPRESSOR, NO MALFUNCTION WAS FOUND DURING EXTENSIVE TESTING THAT COULD BE DIRECTLY LINKED TO THE REPORT EVENT. THE ALARM SYSTEM ALWAYS OPERATED AS PER SPECIFICATIONS DURING EXTENSIVE TESTING. HOWEVER, THE LEVELS OF DUST CONTAMINATION SEEN ON THIS VENTILATOR AND COMPRESSOR, AND THE OVERALL POOR CONDITION WOULD MAKE IT SUSCEPTIBLE TO RANDOM MALFUNCTIONS. THE LACK OF ANY SIGNIFICANT SERVICE HISTORY INFORMATION, THE MISSING COMPRESSOR FILTERS, AND NON-STANDARD PARTS FURTHER REDUCES CONFIDENCE IN THE ABILITY OF THIS VENTILATOR TO PERFORM TO SPECIFICATION. IN CONCLUSION, ALTHOUGH NO SPECIFIC FUNCTIONAL FAILURE WAS REPORTED, A NUMBER OF MINOR FUNCTIONAL ISSUES WERE NOTED DURING THE INVESTIGATION. NONE OF WHICH COULD BE ATTRIBUTED AS A DIRECT CONTRIBUTING FACTOR TO THE REPORTED INCIDENT. THE USE OF UNAPPROVED COMPONENTS (BACKUP BATTERY PACK AND OXYGEN SENSOR), AND THE LACK OF RECOMMENDED PREVENTIVE MAINTENANCE POINT TO CUSTOMER MISUSE OF THE PRODUCT, RESULTING IN A REDUCED LEVEL OF PRODUCT RELIABILITY AND PERFORMANCE.

    Additional Manufacturer Narrative · 1

    COVIDIEN HAS REQUESTED THAT THE DEVICE BE RETURNED FOR INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT A PATIENT DEATH OCCURRED DURING USE OF THE 840 VENTILATOR. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438948 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Death