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

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).

• Brand Name: BIOTEL HOLTER MONITOR
• Type of Device: ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
• Manufacturer (Section D): BIOTEL / PHILIPS NORTH AMERICA LLC
• MDR Report Key: 12711527
• MDR Text Key: 279259189
• Report Number: MW5105001
• Device Sequence Number: 1
• Product Code: MWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: EPATCH
• 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