BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1245439 · Received November 21, 2008

    Report

    Report Number
    2021710-2008-00097
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 19, 2008
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH SENT A FAX TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPETITIVE. CARDINAL HEALTH IS WORKING THROUGH THEIR TECH SUPPORT DEPARTMENT IN ORDER TO GET THE USER FACILITY TO RELEASE THE DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[NAME REMOVED] PAGE. HE WANTED TO REPORT TWO 3100A "FAILURES". I CALLED HIM BACK AND HE EXPLAINED THAT ONE "FAILED" ON A PATIENT AND ANOTHER VENT "FAILED" DURING THE EVALUATION OF DUPLICATING THE ORIGINAL COMPLAINT. HE DOESN'T KNOW THE SETTINGS, BUT HE STATED THAT THERE WAS A CIRCUIT DISCONNECT, THE DRIVER STOPPED, AND NO ALARMS". THE PATIENT INCIDENT HAPPENED. I ASKED HIM FOR THE REASON IT HAS TAKEN SO LONG TO REPORT THAT INCIDENT TO US. HE STATED THAT HE DOESN'T KNOW WHY NO ONE HAS CONTACTED US. RISK MANAGEMENT SEQUESTERED THE VENT PENDING THEIR EVALUATION. RISK MANAGEMENT EVALUATED THEIR SECOND 3100A LAST NIGHT. THEY ONLY HAVE THESE TWO 3100AS AT THEIR FACILITY. THEY FOUND THAT AFTER "DISCONNECTING DIFFERENT TUBING", THEY COULD REPRODUCE THE INCIDENT IN WHICH NO ALARMS WOULD OCCUR. I ASKED HIM FOR THE SETTINGS. HE SAID THAT HE DIDN'T KNOW. HE STATED THAT HE BELIEVES THAT RISK MANAGEMENT WILL BE CALLING US REQUESTING A SERVICE DISPATCH. HE ASKED IF THE 3100A HAD ANY SOFTWARE UPDATES THAT PERHAPS THEY DID NOT RECEIVE. I EXPLAINED TO HIM THAT THERE IS NO SOFTWARE INSTALLED IN THE 3100A VENTILATORS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73LSZ VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA