MAUDE Adverse Event Report: BARDY DIAGNOSTICS INC. BARDY DIAGNOSTICS CARNATION AMBULATORY MONITOR; RECORDER, MAGNETIC TAPE, MEDICAL

Model Number B1000R1400

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2020

Event Type  malfunction  

Event Description

I had a problem with bardy diagnostics carnation ambulatory monitor.It was put on at my doctor's office on (b)(6) 2020 for a two week test.I was told it was ok to shower as long as i didn't let water directly stream onto the device, and the shower was brief.3 days later on a saturday, after 3 brief showers, about half of the device fell off.Although i had no idea if the monitor still worked, i used waterproof tape and taped it back onto my chest.When i spoke to the doctor on the following monday, they, too, had no idea if it was still obtaining valid data.For the rest of the test period, i just applied fresh waterproof tape every day to hold it in place.I had to abort the test after 8 or 9 days because i just couldn't keep it stuck to my chest even with the additional tape.In summary, i believe the adhesive on the device was inadequate.Fda safety report id# (b)(4).

• Brand Name: BARDY DIAGNOSTICS CARNATION AMBULATORY MONITOR
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): BARDY DIAGNOSTICS INC.
• MDR Report Key: 11265455
• MDR Text Key: 230087646
• Report Number: MW5099128
• Device Sequence Number: 1
• Product Code: DSH
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: B1000R1400
• Device Lot Number: 083120
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 78