BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 3961150 · Received May 28, 2014

    Report

    Report Number
    2021710-2014-00028
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION (S) WITH A USER FACILITY REP. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SVC REP. THE CAREFUSION FIELD SVC REP EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY ALARM DISPLAY PCBA. THE CAREFUSION FIELD SVC REP REPLACED THE ALARM DISPLAY PCBA, PERFORMED A SEVEN YEAR PREVENTATIVE MAINTENANCE AND TESTED THE DEVICE PER THE SVC MANUAL TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION OF THE DEVICE WAS RETURNED TO THE CUSTOMER READY TO BE PLACED BACK TO SVC. CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER FOR THE RETURN OF THE ALLEGED FAULTY ALARM DISPLAY PCBA FOR EVAL. AS OF (B)(4) 2014 THE ALLEGED FAULTY ALARM DISPLAY PCBA HAS NOT BEEN RECEIVED. ONCE THE ALARM DISPLAY PCBA HAS BEEN RECEIVED AND THE EVAL COMPLETED, A F/U MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP (S). "[NAMED REMOVED] IN BIOMED CALLED. HE SAID HE WOULD LIKE A SVC CALL ON THE RT'S STATED THAT THE MAP ALARMS WILL LIGHT UP ON THE LED'S BUT THERE IS NO AUDIBLE ALARM. I ASKED HIM IF THERE IS AN AUDIBLE ALARM FOR EVERYTHING ELSE, HE SAID HE DIDN'T KNOW. HE SAID THAT THEY HAD THE UNIT RUNNING ON A PT AND NOTICED THE LED'S WERE COMING ON FOR THE MAP ALARM BUT NO AUDIBLE ALARM NOTED. HE SAID AS FAR AS HE KNOWS THERE WAS NO PT HARM. THE UNIT WAS SWAPPED OUT AND IS IN THE BIOMED SHOP TO BE LOOKED AT. GAVE HIM SVC RATES FOR TRAVEL AND LABOR. I ALSO EXPLAINED TO HIM I DON'T SEE ANY HISTORY OF A 7 YR PM BEING DONE ON THIS UNIT SO THAT IS OVERDUE. HE UNDERSTOOD AND AT THIS POINT THEY WANT THE UNIT LOOKED AT FOR THE ALARM ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314925 SENSORMEDICS VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1