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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC EPATCH; DETECTOR AND ALARM, ARRHYTHMIA
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BRAEMAR MANUFACTURING, LLC EPATCH; DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Device Problems Premature Discharge of Battery (1057); Unable to Obtain Readings (1516)
Patient Problem Dizziness (2194)
Event Date 12/17/2018
Event Type  malfunction  
Event Description
Holter monitor was placed on patient at 1500.Monitor was to be worn for 48 hours.Patient was admitted to er at 1640 due to dizziness.Patient returned monitor and low data was observed upon upload at 1530.Biotel heart company was informed of low data and informed technician that only 2.5 hours of data was obtained.Monitor stopped recording data around 1730.Provider was informed of monitor's early end time and it was determined that a second monitoring period would not be necessary.Holter monitor has been set aside to be returned to biotel for inspection.Ensure monitors are fully charged prior to connection and inform patients on importance of not removing device prior to stated end time and not getting device wet while in their possession.
 
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Brand Name
EPATCH
Type of Device
DETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
BRAEMAR MANUFACTURING, LLC
1285 corporate center dr ste 150
eagan MN 55121
MDR Report Key8260254
MDR Text Key133528614
Report Number8260254
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2018
Event Location Hospital
Date Report to Manufacturer01/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age13505 DA
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