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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTEL / PHILIPS NORTH AMERICA LLC BIOTEL HOLTER MONITOR ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)

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BIOTEL / PHILIPS NORTH AMERICA LLC BIOTEL HOLTER MONITOR ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) Back to Search Results
Model Number EPATCH
Device Problems Output Problem (3005); Data Problem (3196)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Product does not have a failsafe and allowed for multiple patients to be given the same holter results. Device did not record new data, just allowed to change demographics and when uploaded old patient information. The new devices we have received from the company will blink red if old patient data is on the device. The devices we were provided were flashing green like they were recording but did not just continue to hold old data not unique to the patient. We have at least 39 patients involved. Fda safety report id # (b)(4).
 
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Brand NameBIOTEL HOLTER MONITOR
Type of DeviceELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
Manufacturer (Section D)
BIOTEL / PHILIPS NORTH AMERICA LLC
MDR Report Key12711527
MDR Text Key279259189
Report NumberMW5105001
Device Sequence Number1
Product Code MWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEPATCH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
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