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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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BOSTON SCIENTIFIC CORPORATION CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 86620
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2023
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 a procedure a clearsign amplifier was selected for use.It was found that the device had a black screen.The procedure was not completed due to this event.The patient is stable, no patient complication or other additional intervention reported.Whether the date of the procedure was changed was unknown.
 
Event Description
During a procedure a clearsign amplifier was selected for use.It was found that the device had a black screen.The procedure was not completed due to this event.The patient is stable, no patient complication or other additional intervention reported.Whether the date of the procedure was changed was unknown.
 
Manufacturer Narrative
The device has not been received for analysis.However, a work order required a field service engineer (fse) to go on site.The fse received an error when starting up the system confirming the reported allegation.The software was reinstalled.Therefore, it can be concluded that software was the most probable cause of the event.
 
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Brand Name
CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
CREATION TECHNOLOGIES INCORPORATED
8999 fraserton court
burnaby, bc V5J 5 H8
CA   V5J 5H8
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key16555870
MDR Text Key311512734
Report Number2124215-2023-12130
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number86620
Device Catalogue Number86620
Device Lot Number1A770841
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2013
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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