BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHYTHMIA HDX

    MDR report key: 23316616 · Received October 16, 2025

    Report

    Report Number
    2124215-2025-73360
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 22, 2025
    Report Date
    December 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729948407
    PMA / PMN Number
    K192438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    PREMARKET / 510(K) # K162793, K173837, K192438. THE ALLEGATION(S) REGARDING THE REPORTED RHYTHMIA HDX WERE CONFIRMED PER FIELD SERVICE ENGINEER WORK ORDER. IT WAS DISCOVERED THAT THE BOOT LOOP WAS CAUSED BY AN EXTERNAL HARD DRIVE CONNECTED VIA USB, FROM WHICH THE SYSTEM ATTEMPTED TO BOOT. AFTER REMOVING THE HARD DRIVE, THE WORKSTATION BOOTED CORRECTLY. THE SYSTEM IS FULLY FUNCTIONAL AND READY FOR OPERATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WORKSTATION FAILED TO BOOT. SUBSEQUENTLY THE PROCEDURE WAS CANCELLED. DURING PREPARATION FOR A PROCEDURE, A RHYTHMIA HDX WORKSTATION PC WAS SELECTED FOR USE. THE WORKSTATION FAILED TO BOOT. AFTER MULTIPLE RESTART ATTEMPTS, THE SYSTEM REMAINED NON-FUNCTIONAL, EVEN AFTER WAITING APPROXIMATELY 15 MINUTES. ISSUE WAS UNABLE TO BE RESOLVED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT AND IT'S UNKNOWN IF PATIENT SEDATION WAS PERFORMED. EQUIPMENT WILL BE REPLACED BY A NEWER VERSION. THE EQUIPMENT WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WORKSTATION FAILED TO BOOT. SUBSEQUENTLY THE PROCEDURE WAS CANCELLED. DURING PREPARATION FOR A PROCEDURE, A RHYTHMIA HDX WAS SELECTED FOR USE. AFTER MULTIPLE RESTART ATTEMPTS, THE SYSTEM REMAINED NON-FUNCTIONAL, EVEN AFTER WAITING APPROXIMATELY 15 MINUTES. THE PROCEDURE WAS CANCELLED AND IT'S UNKNOWN IF SEDATION WAS PERFORMED. THE WORKSTATION CANNOT BE RETURNED BY THE REPORTER. THE RHYTHMIA SYSTEM WAS REPAIRED IN FOUR APPOINTMENTS. ON (B)(6) 2025, A SOFTWARE UPDATE FROM VERSION 5.1 TO VERSION 6.0.1 WAS PERFORMED ON-SITE. HOWEVER, AFTER INSTALLING THE NEW SOFTWARE, THE WORKSTATION REPEATEDLY GOT STUCK IN A BOOT LOOP DURING STARTUP. SUBSEQUENTLY, ALL INTERNAL CONNECTIONS WERE CHECKED TO RULE OUT A POSSIBLE LACK OF COMMUNICATION WITH THE INTERNAL HARD DRIVE. ADDITIONALLY, VARIOUS BIOS SETTINGS WERE TESTED, BUT THIS ALSO DID NOT PROVIDE A SOLUTION. ON (B)(6) 2025, AFTER CONSULTING WITH THE USERS, THE WORKSTATION WAS TAKEN AWAY AND A FACTORY RESET TO SOFTWARE VERSION 4.0.1 WAS PERFORMED. FROM THIS POINT ON, SUCCESSIVE UPDATES TO VERSION 5.0.1 AND FINALLY TO THE TARGET VERSION 6.0.1 WERE CARRIED OUT. THE SYSTEM THEN BOOTED WITHOUT ERRORS AND WAS READY FOR USE. ON (B)(6) 2025, THE WORKSTATION WAS REINSTALLED AND TESTED ON-SITE. HOWEVER, THE BOOT LOOP ERROR OCCURRED AGAIN, WHICH LED TO THE SUSPICION OF A DEFECT IN THE WORKSTATION PC HARDWARE. DUE TO THE SYSTEM'S AGE, A NEW PC WAS ORDERED FOR FURTHER TROUBLESHOOTING. ON (B)(6) 2025, THE REPAIR WAS SCHEDULED TO BE COMPLETED WITH THE NEW PC. HOWEVER, DURING COMMISSIONING, IT WAS DISCOVERED THAT THE BOOT LOOP WAS CAUSED BY AN EXTERNAL HARD DRIVE CONNECTED VIA USB, FROM WHICH THE SYSTEM ATTEMPTED TO BOOT. AFTER REMOVING THE HARD DRIVE, THE WORKSTATION BOOTED CORRECTLY. TO PREVENT FUTURE PROBLEMS, APPROPRIATE NOTICES WERE PLACE ON THE EXTERNAL HARD DRIVE AND THE USB PORT, ADVISING THAT THE DRIVE SHOULD NOT BE CONNECTED UNTIL AFTER THE SYSTEM HAS BOOTED. THE NEWLY DELIVERED PC WAS THEREFOR RETURNED. THE SIS WAS SUBSEQUENTLY UPDATED TO THE COMPATIBLE SOFTWARE VERSION. FOLLOWING THE REPAIR, THE REQUIRED PREVENTIVE MAINTENANCE (PM) WAS PERFORMED, INCLUDING FUNCTIONAL TESTING AND SAFETY CHECKS (STK), DOCUMENTED IN WORK ORDER (B)(4). THE SYSTEM IS FULLY FUNCTIONAL AND READY FOR OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375477 RHYTHMIA HDX COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION M004RH40100 1047270647 08714729948407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown