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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. BODY GUARDIAN MINI REMOTE CARDIAC MONITOR; DETECTOR AND ALARM, ARRHYTHMIA
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BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. BODY GUARDIAN MINI REMOTE CARDIAC MONITOR; DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/22/2024
Type of Reportable Event Malfunction
Event or Problem Description
(b)(6) health system has been notified by preventice/boston scientific of an issue with their algorithm that identifies ventricular tachycardia (vt) for mct/cem studies (body guardian mini).The software issue may cause vt to not be identified resulting in the health care facility not receiving a critical alert notification or report, and the vt strip/event not being included in the end of service report sent to the healthcare facility.Some vt is being caught and some is missed; the amount of each is unknown.This is not an equipment issue but software issue.Boston scientific identified the problem 04/04/2024 and notified (b)(6) 04/16/2024.At the present time we are unaware of patient harm but are investigating.Bodyguardian mini is the device, but the issue is with the software.Boston scientific this is a software issue.Not a monitor problem but a software problem.Manufacturer reported to us.Boston scientific cardiac diagnostics 1717 n.Sam houston pkwy w, houston, tx 77038.
 
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Brand Name
BODY GUARDIAN MINI REMOTE CARDIAC MONITOR
Common Device Name
DETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
MDR Report Key19449819
Report NumberMW5155698
Device Sequence Number7181673
Product Code DSI
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 05/29/2024
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 Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/31/2024
Patient Sequence Number1
Patient SexUnknown
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