BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSORMEDICS

    MDR report key: 1036603 · Received May 1, 2008

    Report

    Report Number
    2021710-2008-00035
    Event Type
    Death
    Date Received
    May 1, 2008
    Date of Event
    March 17, 2008
    Report Date
    May 1, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED AT: PERINATAL CENTRE, ANOTHER COUNTRY. CARDINAL HEALTH SENT AN E-MAIL VIA OUR DISTRIBUTOR TO ANOTHER COUNTRY DISTRIBUTOR, SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT, PRIMARY & SECONDARY CAUSES OF DEATH OF THE PATIENT, AND THE REPAIR OF THE DEVICE. THE DISTRIBUTOR, RESPONDED WITH THE FOLLOWING; "I CANNOT SUPPLY YOU WITH ANY OTHER INFORMATION. THE HOSPITAL HAS CLOSED THIS INCIDENT. I CAN ADD ONLY, THAT THE SOUND ALARM SOUNDED." THE DISTRIBUTOR, DID NOT SUBMIT A USER FACILITY/DISTRIBUTOR REPORT TO THE MANUFACTURER. ANOTHER COUNTRY DISTRIBUTOR, EVALUATED THE DEVICE AND FOUND THAT THE TUBE THAT CONNECTS THE REGULATOR TO THE POP-OFF VALVE HAD BECOME DISCONNECTED FROM THE BARBED FITTING ON THE REGULATOR. THE DISTRIBUTOR RECONNECTED THE TUBE TO THE REGULATOR PR7 AND SECURED IT WITH A METAL BAND (HOSE CLAMP). IN AUGUST OR SEPTEMBER 2007, THE DISTRIBUTOR HAD REPLACED THE REGULATOR IN THIS DEVICE. THE HOSE MAY NOT HAVE BEEN FULLY SEATED ONTO THE BARBED FITTING OF THE REGULATOR AT THAT TIME. THUS, DEVICE MAINTENANCE MAY HAVE CONTRIBUTED TO THE FAILURE OF THE DEVICE. NO COMPONENT OR SYSTEM TREND HAS BEEN IDENTIFIED AND THIS IS CONSIDERED TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT, CONDITION OF THE PATIENT, AND REPAIR OF THE DEVICE, WAS REPORTED TO VIASYS (OUR REPRESENTATIVE) BY THE FOREIGN DISTRIBUTOR IN ANOTHER COUNTRY AND RELAYED TO CARDINAL HEALTH VIA EMAIL AND DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST. [NAME REMOVED] FROM CENTER THAT THIS VENT WAS BEING USED ON A PATIENT AT PERINATAL CENTRE (ANOTHER COUNTRY) WHEN THE VENT "FAILED." FAILURE DESCRIPTION: "A BIG LEAKAGE IN BASE FLOW CONTOUR IN THE DEVICE. IT WAS A SUDDEN DETACHMENT OF A TUBE FROM PRESSURE REGULATOR DURING VENTILATION OF THE PATIENT. THIS TUBE CONNECTS A REGULATOR AND THE POP-OFF VALVE (75 PS)." DATE OF OCCURRENCE: 2008. MALFUNCTION CAUSING PATIENT HARM? "THE PATIENT HAS DIED". STATUS OF EQUIPMENT: "CONNECTION IS FIXED BY A METAL COLLAR. THE DEVICE IS TESTED AND TRANSFERRED TO CUSTOMER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS HIGH FREQUENCY OSCILLATORY VENT LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death