BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMIA HDXTM MAPPING SYSTEM

    MDR report key: 19850813 · Received July 29, 2024

    Report

    Report Number
    2124215-2024-46570
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 4, 2024
    Report Date
    September 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE SIGNAL STATION WAS NOT RETURNED FOR ANALYSIS, HOWEVER, A FIELD SERVICE INSPECTION WAS CONDUCTED. INITIAL INSPECTION OF EQUIPMENT INDICATED THAT SOFTWARE VERSION STILL AT V1.4, PERFORMED SOFTWARE DOWNGRADE OF WORKSTATION TO V4.01 TO ALLOW UPGRADE OF BOTH COMPONENTS TO V4.5 BUT FOUND THAT SUPPLIED UNIT WAS MISSING FPGA-03 ECG UPGRADE AND IT WAS UNABLE TO PROCEED ANY FURTHER WITH EXISTING UNIT. THUS, IT WAS ABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATION OF "NO SIGNAL".

    Description of Event or Problem · 0

    THE RHYTHMIA HDX MAPPING SYSTEM'S SIGNAL STATION WAS SELECTED FOR USE DURING THE PROCEDURE. IT WAS REPORTED THAT AN ELECTRICAL BLANKET WAS PLACED CLOSE TO THE SYSTEM AND AIR VENT OF THE SIGNAL STATION WAS BLOCKED, WHICH IS AGAINST THE DIRECTIONS FOR USE. DURING THE PROCEDURE THE BACKPATCH WAS DISCONNECTED ON THE SYSTEM DESPITE STILL BEING CONNECTED. DESPITE SYSTEM RESTART THE ISSUE PERSISTED. UPON FURTHER INSPECTION, THEY OBSERVED THAT AN ELECTRIC PATIENT BLANKET WARMER HAD BEEN POSITIONED BY LABORATORY STAFF CLOSE TO LOCALIZATION GENERATOR AT HEAD OF BED AND THE AIR VENT HAD BEEN PLACED AGAINST THE LOCALIZATION GENERATOR. TOUCHING THE DARK GREY SECTION OF LOCALIZATION GENERATOR CONFIRMED THAT HOT AIR HAD BEEN BLOWING ONTO THE LOCALIZATION GENERATOR AND THE DARK GREY BAR ADJACENT TO THE BLANKET WARMER; THE AIR VENT WAS HOT TO TOUCH. AIR VENT WAS MOVED AWAY FROM LOCALIZATION GENERATOR AND POWER TO SIGNAL STATION (SIS) WAS SHUT DOWN TO ALLOW TIME FOR LOCALIZATION GENERATOR TO RETURN TO NORMAL FUNCTIONING TEMPERATURE TO TOUCH. AFTER FIVE MINUTES THE LOCALIZATION GENERATOR FELT NORMAL TO THE TOUCH, SO SIS WAS REBOOTED. THIS RESOLVED THE ORIGINAL ISSUE AND BACKPATCH WAS VISIBLE, THE CASE CONTINUED WITH MAPPING FUNCTION RESTORED. HOWEVER, A SHORT TIME LATER AFTER SOME MAPPING HAD OCCURRED, THE ISSUE RETURNED, WITH BACKPATCH DISAPPEARING WITH AN ERROR WARNING STATING BACKPATCH DISCONNECTED. WHEN THEY RETURNED TO THE PATIENT'S SIDE ON THE TABLE TO FURTHER INVESTIGATE, A STRONG ELECTRICAL BURNING SMELL WAS NOTICED FROM THE SIS AIR VENTS. POWER WAS DISCONNECTED FROM UNIT, ALL THE CABLES DISCONNECTED, AND SIS SWIFTLY REMOVED FROM THE ENVIRONMENT. WHILE THE REDO PULMONARY VEIN ISOLATION WAS COMPLETED SUCCESSFULLY, THE MAPPING OF THE PREMATURE VENTRICULAR CONTRACTIONS (PVC) COULD NOT BE COMPLETED AS PROCEDURE WAS ABORTED DUE TO THIS EVENT. IT WAS NOTED THAT STRONG ELECTRICAL SMELL WAS STILL OBSERVED FROM THE SIS TWO HOURS POST PROCEDURE WHILE IT WAS IN A VENTILATED ROOM AWAY FROM LABORATORY AREA. THE SIGNAL STATION WAS REPLACED. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE AVAILABILITY FOR RETURN IS UNKNOWN.

    Description of Event or Problem · 0

    THE RHYTHMIA HDX MAPPING SYSTEM'S SIGNAL STATION WAS SELECTED FOR USE DURING THE PROCEDURE. IT WAS REPORTED THAT AN ELECTRICAL BLANKET WAS PLACED CLOSE TO THE SYSTEM AND AIR VENT OF THE SIGNAL STATION WAS BLOCKED, WHICH IS AGAINST THE DIRECTIONS FOR USE. DURING THE PROCEDURE THE BACKPATCH WAS DISCONNECTED ON THE SYSTEM DESPITE STILL BEING CONNECTED. DESPITE SYSTEM RESTART THE ISSUE PERSISTED. UPON FURTHER INSPECTION, THEY OBSERVED THAT AN ELECTRIC PATIENT BLANKET WARMER HAD BEEN POSITIONED BY LABORATORY STAFF CLOSE TO LOCALIZATION GENERATOR AT HEAD OF BED AND THE AIR VENT HAD BEEN PLACED AGAINST THE LOCALIZATION GENERATOR. TOUCHING THE DARK GREY SECTION OF LOCALIZATION GENERATOR CONFIRMED THAT HOT AIR HAD BEEN BLOWING ONTO THE LOCALIZATION GENERATOR AND THE DARK GREY BAR ADJACENT TO THE BLANKET WARMER; THE AIR VENT WAS HOT TO TOUCH. AIR VENT WAS MOVED AWAY FROM LOCALIZATION GENERATOR AND POWER TO SIGNAL STATION (SIS) WAS SHUT DOWN TO ALLOW TIME FOR LOCALIZATION GENERATOR TO RETURN TO NORMAL FUNCTIONING TEMPERATURE TO TOUCH. AFTER FIVE MINUTES THE LOCALIZATION GENERATOR FELT NORMAL TO THE TOUCH, SO SIS WAS REBOOTED. THIS RESOLVED THE ORIGINAL ISSUE AND BACKPATCH WAS VISIBLE, THE CASE CONTINUED WITH MAPPING FUNCTION RESTORED. HOWEVER, A SHORT TIME LATER AFTER SOME MAPPING HAD OCCURRED, THE ISSUE RETURNED, WITH BACKPATCH DISAPPEARING WITH AN ERROR WARNING STATING BACKPATCH DISCONNECTED. WHEN THEY RETURNED TO THE PATIENT'S SIDE ON THE TABLE TO FURTHER INVESTIGATE, A STRONG ELECTRICAL BURNING SMELL WAS NOTICED FROM THE SIS AIR VENTS. POWER WAS DISCONNECTED FROM UNIT, ALL THE CABLES DISCONNECTED, AND SIS SWIFTLY REMOVED FROM THE ENVIRONMENT. WHILE THE REDO PULMONARY VEIN ISOLATION WAS COMPLETED SUCCESSFULLY, THE MAPPING OF THE PREMATURE VENTRICULAR CONTRACTIONS (PVC) COULD NOT BE COMPLETED AS PROCEDURE WAS ABORTED DUE TO THIS EVENT. IT WAS NOTED THAT STRONG ELECTRICAL SMELL WAS STILL OBSERVED FROM THE SIS TWO HOURS POST PROCEDURE WHILE IT WAS IN A VENTILATED ROOM AWAY FROM LABORATORY AREA. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE AVAILABILITY FOR RETURN IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED. THE SIGNAL STATION WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399348 RHYTHMIA HDXTM MAPPING SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE NMD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown