MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDX; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	M004RH40100
Medical Device Problem Codes	Application Program Problem (2880); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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
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.
Event or Problem Description
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.

• Brand Name: RHYTHMIA HDX
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23316616
• Report Number: 2124215-2025-73360
• Device Sequence Number: 14694422
• Product Code: DQK
• UDI-Device Identifier: 08714729948407
• UDI-Public: (01)08714729948407(11)240613(10)1047270647
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M004RH40100
• Device Catalogue Number: M004RH40100
• Device Lot Number: 1047270647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/23/2025
• Date Device Manufactured: 06/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown