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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC EPATCH; RECORDER, MAGNETIC TAPE, MEDICAL
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BRAEMAR MANUFACTURING, LLC EPATCH; RECORDER, MAGNETIC TAPE, MEDICAL Back to Search Results
Device Problem Patient Data Problem (3197)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2020
Event Type  malfunction  
Event Description
Physician was reviewing holter results as notification was received for 30 day event monitor placed s/p discharge from tavr.Physician noted that holter report shows all sinus rhythm and no atrial fibrillation yet multiple ekg's from immediately before and after holter monitor placement all show a-fib.Review by vendor confirms the data on this patient's holter monitor report matches the data submitted for the patient who wore that specific monitor (based on s/n) prior to this patient.Therefore, the report data from the holter monitor even with the patients correct name is truly from another patient.There was no data recorded for the affected patient during the time she wore the holter monitor.Result of monitor did not have any direct negative impact on patients plan of care.
 
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Brand Name
EPATCH
Type of Device
RECORDER, MAGNETIC TAPE, MEDICAL
Manufacturer (Section D)
BRAEMAR MANUFACTURING, LLC
1285 corporate center dr suite 150
eagan MN 55121
MDR Report Key10874909
MDR Text Key217423529
Report Number10874909
Device Sequence Number1
Product Code DSH
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 10/13/2020
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 No Information
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/13/2020
Event Location Other
Date Report to Manufacturer11/20/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/20/2020
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age25550 DA
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