BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURITAN BENNETT

    MDR report key: 4969724 · Received August 5, 2015

    Report

    Report Number
    8020893-2015-00729
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 15, 2015
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE RETURNED UNIT WAS CONDUCTED AND NO ANOMALIES WERE FOUND. THE BREATH DELIVERY CENTRAL PROCESSING UNIT PRINTED CIRCUIT BOARD (BD CPU PCBA) USED ON THIS VENTILATOR SYSTEM IS NO LONGER AVAILABLE AS A REPLACEMENT PART. THIS PCBA WAS REDESIGNED AND PRODUCTION OF THIS BD CPU PCBA CEASED AFTER THE RELEASE OF THE NEW DESIGN AND IS NOT AVAILABLE FOR SALE. IT WAS REPORTED THAT NO OPERATING SYSTEM SOFTWARE EXISTS ON THIS BOARD. THE CORRECT SOFTWARE VERSION WAS LOADED SUCCESSFULLY. THE UNIT POWERED UP NORMALLY AND NO ERRORS WERE RECORDED IN THE DIAGNOSTIC LOGS. CALIBRATION, EXTENDED SELF TEST (EST) AND SHORT SELF TEST (SST) TESTS WERE RUN SUCCESSFULLY WITHOUT ANY ERRORS. THE UNIT WAS THEN PUT INTO NORMAL VENTILATION MODE. THE UNIT RAN IN VENTILATION MODE FOR A MINIMUM OF 24 HOURS. ON REVIEW OF THE VENTILATOR DIAGNOSTIC LOGS, NO ERRORS WERE OBSERVED. NOR WERE ANY ALARMS WERE OBSERVED DURING THE RUN IN PERIOD. CONCLUSION: NO FAULT FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, AN OPERATION FAILURE OCCURRED ON THE VENTILATOR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT ANY REPORTED HARM. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514327 PURITAN BENNETT CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention