MAUDE Adverse Event Report: PHILIPS BIOTEL /BRAEMAR MANUFACTURING, LLC PATCH; ELECTRODE, ELECTROCARDIOGRAPH

Device Problems Device Alarm System (1012); Power Problem (3010); Patient Device Interaction Problem (4001)

Patient Problem Contact Dermatitis (4546)

Event Date 01/27/2022

Event Type  Injury  

Event Description

I was supplied with a philips biotel mcot event monitor by my cardiologist on (b)(6) 2022.I have had several bouts of debilitating atrial fibrillation in the past.I received a couple of cardioversions which relieved the a-fib for about 6 months and ultimately had a cryogenic cardiac ablation which for the most part has seemed to be effective.I still seem to have very infrequent, very short term cases of a-fib hence the event monitor to determine what is actually happening.The initial unit i received came with a "monitor", (a (b)(6) cell phone) that would go in to various alarm modes if it was not charged a minimum of three times a day.Most of the audible alarms gave no indication as to what the problem was.After 2 to 3 days of this i contacted biotel.They indicated the unit was malfunctioning and promptly sent me a new unit which i activated on (b)(6) 2022.The new unit would still alarm intermittently without any apparent reason or explanation, but the monitor would hold a charge for at least a day.I continued to wear the new unit until the "sensor" indicated it needed recharging.The sensor is attached via an adhesive patch using a temple to place it in the same position every time it is applied.By the time i removed the patch to charge the sensor on (b)(6) 2022, i had a patch in the same location for about two weeks.I discovered some sort of dermatitis that looked like blisters or lesions upon removal of the patch.Given the dermatitis and the fact that the unit had alarmed and woken me from my sleep without explanation on 5 successive occasions starting at 3:30 am that morning, i elected to discontinue use.A quick check of the internet discovers dozens of individuals reporting circumstances exactly like mine on other websites that i assume are not tracked by the fda.Perhaps they should be.Fda safety report id # (b)(4).

• Brand Name: PATCH
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS BIOTEL /BRAEMAR MANUFACTURING, LLC
• MDR Report Key: 13394997
• MDR Text Key: 284840889
• Report Number: MW5107080
• Device Sequence Number: 3
• 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: Patient
• Type of Report: Initial
• Report Date: 01/27/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: HYDROCHLOROTHIAZIDE; LISINOPRIL ; METOPROLOL; OXYCODONE; PRE-GABALIN; VITAMIN B COMPLEX
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White