BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE¿ X DISPLAY WORKSTATION

    MDR report key: 18698059 · Received February 13, 2024

    Report

    Report Number
    2184149-2024-00030
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 24, 2024
    Report Date
    September 10, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQK
    UDI-DI
    05415067037725
    PMA / PMN Number
    K212061, K22
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ENSITE X DISPLAY WORKSTATION (DWS) WAS RECEIVED. THE DWS WAS CONNECTED WITH A KNOWN GOOD ENSITE X AMPLIFIER AND LC/LC FIBER OPTIC CABLE. THE REPORTED SYMPTOM WAS DUPLICATED AS THE AMPLIFIER WOULD NOT COMMUNICATE WITH THE DWS. THE SMALL FORM-FACTOR PLUGGABLE RECEIVER (SFP) WAS EXCHANGED WITH A KNOWN GOOD SFP AND STILL NO COMMUNICATIONS WERE ESTABLISHED. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE REMAINED UNDETERMINED AS NO FURTHER EVALUATION COULD BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ONE ENSITE X DISPLAY WORKSTATION (DWS) WAS RECEIVED. THE DWS WAS CONNECTED WITH A KNOWN GOOD ENSITE X AMPLIFIER AND LC/LC FIBER OPTIC CABLE. THE REPORTED SYMPTOM WAS DUPLICATED AS THE AMPLIFIER WOULD NOT COMMUNICATE WITH THE DWS. THE SMALL FORM-FACTOR PLUGGABLE RECEIVER (SFP) WAS EXCHANGED WITH A KNOWN GOOD SFP AND STILL NO COMMUNICATIONS WERE ESTABLISHED. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE WAS IDENTIFIED TO THE INTERNAL SOFTWARE CONFIGURATION FILES OF THE HARD DISK DRIVE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED.

    Description of Event or Problem · 0

    DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE ENSITE X AMPLIFIER WAS NOT COMMUNICATING WITH THE ENSITE X DISPLAY WORKSTATION RESULTING IN CANCELLATION OF THE PROCEDURE. A SECOND NEW FIBER WAS ATTEMPTED, RESTARTED THE SYSTEM, RESEATED THE SFP CONNECTIONS, DISCONNECTED THE ETHERNET DATA PORT WITH NO RESOLVE. THE ENSITE X AMPLIFIER WAS REPLACED, BUT THERE WAS STILL NO COMMUNICATION. THE SFP WERE EXCHANGED WITH A SECOND AMPLIFIER, BUT THE ISSUE WAS NOT RESOLVED. THE ENSITE X DISPLAY WORKSTATION WAS THEN ALLEGED TO BE THE ISSUE. THE CASE WAS CANCELLED WITH A PATIENT ON THE TABLE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157749 ENSITE¿ X DISPLAY WORKSTATION COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL ENSITE-DWS-1.1 8275725 05415067037725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown