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

Model Number	87038
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a procedure a rhythmia hdx signal station 2 was selected for use.It was found that the incoming and outgoing signals were not displayed.The procedure was cancelled.No patient complications were reported.It is unknown if the device will be returned for analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.
Event or Problem Description
It was reported that during a procedure a rhythmia hdx signal station 2 was selected for use.It was found that the incoming and outgoing signals were not displayed.The procedure was cancelled.No patient complications were reported.It is unknown if the device will be returned for analysis.It was further reported that the device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that during a procedure a rhythmia hdx signal station 2 was selected for use.It was found that the incoming and outgoing signals were not displayed.The procedure was cancelled.No patient complications were reported.The device has been received for analysis.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the signal station was first visually inspected, and no external abnormalities were observed and the unit powered on.During functional testing there were no outputs from the system, and it did not accept any inputs.A loos connection in the device's front stack was found and when the issue was repaired the signal station became fully functional.Based on all available information boston scientific confirms the allegation in the complaint and the cause was traced to component failure due to the loose part in the front stack.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 18503957
• Report Number: 2124215-2024-01057
• Device Sequence Number: 7811628
• Product Code: DQK
• UDI-Device Identifier: 08714729938712
• UDI-Public: 08714729938712
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2024

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: 87038
• Device Catalogue Number: 87038
• Device Lot Number: S0000936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 01/17/2024; 08/22/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 01/30/2024; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown