MAUDE Adverse Event Report: PHILIPS/LIFEWATCH SERVICES INC. MCT 3L (MOBILE CARDIAC TELEMETRY DEVICE); DETECTOR AND ALARM, ARRHYTHMIA

Model Number MCT 3L

Device Problems Application Program Problem (2880); Battery Problem (2885); Intermittent Communication Failure (4038)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/25/2022

Event Type  Injury  

Event Description

Device description: lifewatch /biotelemetry, inc (acquired by philips) biotel heart mct 3l (mobile cardiac telemetry device) event description: following a diagnosis of transient ischemic attack (tia), the mobile cardiac telemetry device was prescribed to monitor heart rhythm.Patient data was acquired for 21 days.Upon inquiring to lifewatch on march 25, to confirm the date to discontinue data acquisition, the response was that no data could be found: acquisition was never initiated.All data that was acquired and uploaded is lost.Patient was not advised on next steps.This is a significant hazard to patient safety as it delays cardiac rhythm diagnosis and delays treatment to lower risk of patient harm or death from ischemic incidents.Observations: patient complied with instructions in guide to setup (lead attachment, battery install, charging of smart phone etc.) and confirmed understanding with biotel heart support by phone.The android app on the smartphone monitor confirmed: the monitor app was functioning with wireless data connection to the cardiac sensor device; the heart monitoring was functioning and acquiring data; cellular service connection between the smart device to a remote server to deposit cardiac rhythm data (to lifewatch).Multiple times the smartphone monitor device showed apparent upload activity with progress bar.Evidence that expected data acquisition was ongoing were prompt audible alerts when data acquisition was interrupted or potentially imminent: disconnection any of any of the cardiac leads; cardiac sensor device worn by patient was too far from the smartphone monitor (for wireless bluetooth data connection); the sensor battery was low and needed replacement; the smart device battery was low and needed recharge; and when cellular service was weak, endangering the ability to offload cardiac data acquired by sensor device, stored on the monitor.(the cardiac sensor acquires data and sends it to the smartphone monitor via a bluetooth data connection.The monitor can hold up to six hours of data.The monitor app on the smartphone offloads the data to a remote server for analysis and diagnosis.) there was no alert or other indication that cardiac data was not successfully sent from the monitor, or that the data was not successfully stored in the patient's diagnostic record (by lifewatch).Fda safety report id # (b)(4).

• Brand Name: MCT 3L (MOBILE CARDIAC TELEMETRY DEVICE)
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS/LIFEWATCH SERVICES INC.
• MDR Report Key: 13966054
• MDR Text Key: 288376825
• Report Number: MW5108639
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/28/2022

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 Model Number: MCT 3L
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2022
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81MG DAILY; ATORVASTATIN; SYNTHROID
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White