BEUDAMED
    FDA Adverse Event Death Summary report: N

    840 VENTILATOR

    MDR report key: 1660188 · Received April 14, 2010

    Report

    Report Number
    8020893-2010-00167
    Event Type
    Death
    Date Received
    April 14, 2010
    Date of Event
    March 14, 2010
    Report Date
    March 15, 2010
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN NPB CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE DEVICE. THE ERROR AND EVENT LOGS SHOWED NOTHING TO INDICATE A VENTILATOR MALFUNCTION. THE CSE NOTICED THE A/C POWER CONNECTOR WAS DAMAGED AND THE COMPRESSOR WATER TRAP HAD AIR COMING OUT OF IT. DURING FURTHER INSPECTION OF THE COMPRESSOR, THE CSE NOTED THAT THE COMPRESSOR PCB WAS BURNT. THE RESPIRATORY STAFF REPORTED THAT AT THE TIME OF INCIDENT, THE VENTILATOR WAS CONNECTED TO WALL OXYGEN, INDICATING THE COMPRESSOR WOULD NOT HAVE BEEN IN USE. ISSUES FOUND DURING INSPECTION ARE BELIEVED TO BE UNRELATED TO THE EVENT. THIS WAS AN INSPECTION ONLY. THE VENTILATOR/COMPRESSOR WAS NOT REPAIRED.

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT (NPB) RECEIVED AN INQUIRY FOR A VENTILATOR INSPECTION. THE HOSP REPORTED THAT THE UNIT WAS EMITTING A BURNING SMELL AND WAS NOT VENTILATING THE PT OR ALARMING. THE PT WAS REMOVED FROM THE VENTILATOR AND WAS MANUALLY VENTILATED, BUT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK PURITAN BENNETT CORP. 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Death