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

Model Number 87038

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2021

Event Type  malfunction  

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.

Event Description

During preparation for a procedure it was reported that the device rhythmia mapping system overheated and crashed.The procedure was not completed due to this event.The event occurred during preparation.However, the sedation status of the patient was not specified.The patient is stable, no patient complication or other additional intervention reported.

Event Description

During preparation for a procedure it was reported that the device arrhythmia mapping system overheated and crashed.The procedure was not completed due to this event.The event occurred during preparation.However, the sedation status of the patient was not specified.The patient is stable, no patient complication or other additional intervention reported.

Manufacturer Narrative

The signal station was returned to boston scientific for analysis.Visual inspection did not reveal any abnormalities.During functional testing, the system overheated and a burning smell was observed.Error messages were also triggered on the work station.The reported observation was confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: RHYTHMIA HDX
• Type of Device: 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12407719
• MDR Text Key: 269800827
• Report Number: 2134265-2021-11097
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729938712
• UDI-Public: 08714729938712
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K162793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87038
• Device Catalogue Number: 87038
• Device Lot Number: S0000819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1