BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIASYS

    MDR report key: 4192651 · Received October 9, 2014

    Report

    Report Number
    2021710-2014-00058
    Event Type
    Death
    Date Received
    October 9, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE FOREIGN USER FACILITY NOR THE FOREIGN DISTRIBUTOR SUBMITTED A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY THE FOREIGN CORONER'S OFFICE. THE DESCRIPTION/REPORT IN BLOCK "DESC OF EVENT" IS THE ONLY INFORMATION CURRENTLY IN CAREFUSION'S POSSESSION IN REGARDS TO THE INCIDENT. CAREFUSION IS IN THE PROCESS OF COORDINATING WITH THE (B)(6) CORONER'S OFFICE AND (B)(4) TO MAKE ARRANGEMENTS TO HAVE THE INFANT FLOW SIPAP DRIVER MADE AVAILABLE FOR EVALUATION BY A (B)(4) REPRESENTATIVE AND/OR CAREFUSION REPRESENTATIVE. ONCE CAREFUSION HAS MADE ARRANGEMENTS TO HAVE THE INFANT FLOW SIPAP DRIVER EVALUATED AND THE EVALUATION REPORT IS RECEIVED, CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A CAREFUSION VENTILATION COMPLAINT FORM SUBMITTED BY THE DISTRIBUTOR IN THE (B)(4) AND FORWARDED TO CAREFUSION IN (B)(4) VIA EMAIL ATTACHMENT. "[CITY NAME REMOVED] CORONER'S OFFICE IS INVESTIGATING A PATIENT DEATH. THIS SIPAP WAS BEING USED ON THE PATIENT. AT THIS TIME, THERE IS NOT AN ALLEGATION OF A PRODUCT FAULT BUT THE CORONER NEEDS THE MACHINE TO BE EXAMINED TO ANSWER A NUMBER OF QUESTIONS (AS PER BELOW). THE HOSPITAL HAS NOT RETAINED ANY CONSUMABLES FOR ANALYSIS. EMAIL TO [DISTRIBUTOR'S NAME REMOVED] SERVICE SUPERVISOR: FURTHER TO OUR EARLIER CONVERSATION REGARDING THE EXAMINATION OF A SIPAP MACHINE, THERE ARE TWO PARTS TO THE MACHINE WHICH WERE TAKEN FROM [USER FACILITY'S NAME REMOVED]. THE SMALLER SQUARE PART IS MANUFACTURED BY [MANUFACTURER'S NAME REMOVED] AND HAS A SERIAL NUMBER OF (B)(4), THE LARGER RECTANGULAR DEVICE FROM [MANUFACTURER'S NAME REMOVED] HAS A SERIAL NUMBER OF (B)(4). I DO NOT KNOW HOW THEY GO TOGETHER OR HOW THEY WORK, SO YOUR OVERVIEW WOULD BE GREATLY APPRECIATED. THEY ARE STORED AT [LOCATION INFORMATION REMOVED]. THERE IS A PROPERTY NUMBER OF (B)(4) AND THE SHEET HAS BEEN ENDORSED THAT THEY ARE FOR COLLECTION BY A COURIER ON BEHALF OF YOURSELF. 'THE REASON FOR ASKING FOR YOUR ASSISTANCE IS THAT FROM VERY PRELIMINARY FINDINGS, IT APPEARS THAT A FULL TERM BABY HAD BREATHING DIFFICULTIES AND THIS DEVICE WAS USED, CLINICIANS THEN FOUND WHAT THEY BELIEVE TO BE A PNEUMOTHORAX. I NEED TO ESTABLISH IF THIS DEVICE WAS FUNCTIONING CORRECTLY AND WOULD ASK THAT THE FOLLOWING POINTS BE ADDRESSED. AN OVERVIEW OF WHY THIS DEVICE WOULD BE USED, HOW IT OPERATES, AND WHAT IT WOULD ACHIEVE. IS IT POSSIBLE TO OBTAIN A DOWNLOAD OF READINGS FROM THE DEVICE WHEN IT WAS LAST USED. CAN IT BE ESTABLISHED IF THE MACHINE GENERATED THE LEVELS THAT ARE DISPLAYED ON THE DEVICE. CAN THIS MACHINE CAUSE A PNEUMOTHORAX EITHER IF IT IS USED CORRECTLY OR IF THERE IS POTENTIAL FOR INCORRECT USE. ARE THERE ANY SAFEGUARDS TO PREVENT INCORRECT OPERATION. IS THERE A LEVEL OF TRAINING THAT REQUIRES TO BE GIVEN BEFORE THIS MACHINE IS OPERATED. YOU CAN PROBABLY GUESS THAT I HAVE LIMITED KNOWLEDGE OF THIS MACHINE AND ANY HELP THAT YOU CAN PROVIDE IS VERY MUCH APPRECIATED. THERE IS THE POTENTIAL THAT THIS MATTER MAY GO BEFORE (B)(6) SENIOR CORONER MR [NAME REMOVED] AT AN INQUEST AND THAT THE REPORT WHICH YOU SUPPLY COULD BE READ OUT IN THE COURT AND THE FAMILY MAY BE PRESENT AND REQUEST A COPY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637099 VIASYS VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION INFANT FLOW SIPAP DRIVER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA FISHER PAYKEL HUMIDIFIER: SN (B)(4)