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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
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BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL Back to Search Results
Model Number 86620
Device Problem Power Conditioning Problem (1474)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2023
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
During procedure, a clearsign ii amp, 80 channels was selected for use.It was reported that signal interference of body surface was found.The procedure was not completed due to this issue.The patient is stable, no patient complication or other additional intervention reported.Unknown if product is going to be returned.
 
Manufacturer Narrative
Product was not returned but was analyzed on site.Based on the work order, the interference was caused by the loose head of the body surface cable.Replaced a set of body surface cable and the fault was resolved.H3 other text : device was analyzed on site.
 
Event Description
During procedure, a clearsign ii amp, 80 channels was selected for use.It was reported that signal interference of body surface was found.The procedure was not completed due to this issue.The patient is stable, no patient complication or other additional intervention reported.The console has not been returned for analysis.
 
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Brand Name
LABSYSTEM PRO
Type of Device
AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
150 baytech dr.
san jose CA 95134
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key17175427
MDR Text Key317658205
Report Number2124215-2023-27107
Device Sequence Number1
Product Code DRQ
UDI-Device Identifier08714729884897
UDI-Public08714729884897
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K152693
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2023
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 Number1D904535
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2019
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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