Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDX; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDX; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 87038
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2023
Event Type  malfunction  
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 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 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.
 
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 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.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18503957
MDR Text Key332987768
Report Number2124215-2024-01057
Device Sequence Number1
Product Code DQK
UDI-Device Identifier08714729938712
UDI-Public08714729938712
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162793
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/30/2024
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
Device Operator Health Professional
Device Model Number87038
Device Catalogue Number87038
Device Lot NumberS0000936
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/08/2024
Initial Date FDA Received01/12/2024
Supplement Dates Manufacturer Received01/17/2024
Supplement Dates FDA Received01/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2021
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-