MAUDE Adverse Event Report: BARDY DIAGNOSTICS INC. BARDY DIAGNOSTIC CAM; RECORDER, MAGNETIC TAPE, MEDICAL

Model Number B1400

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Due to a cardiac issue and event that occurred, my cardiologist ordered me to wear a heart monitor for 14 days to get a good reading of my heart and to see if another incident could be recorded so as to determine an appropriate treatment or procedure to correct the problem.The bardy diagnostic cam monitor was placed on me.By the 2nd day, the edges of the adhesive stripping started to warp and roll, and on the 3rd day the conduction gel separated from the bottom of the monitor and fell off.Another monitor was placed on me and i was told to tape it on if it started coming off.I shouldn't have had to tape it, but did so with medical tape on the 2nd day.On the 3rd day, the conduction gel again separated and detached from the monitor and fell out the bottom of it.The monitors are over 300.00 not including the cost to be read.I have been charged for both monitors and there is absolutely no way that this monitor will stay on anyone's body for 14 days.Because of the poor quality and failure of the monitors, i am unable to complete my dr's order in compliance of a potentially life-threatening issue.Fda safety report id# (b)(4).

• Brand Name: BARDY DIAGNOSTIC CAM
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): BARDY DIAGNOSTICS INC.
• MDR Report Key: 12861511
• MDR Text Key: 281231253
• Report Number: MW5105519
• Device Sequence Number: 1
• Product Code: DSH
• 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: 11/18/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/23/2022
• Device Model Number: B1400
• Device Lot Number: 031280
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CORTICOSTEROID INJECTION; GABAPENTIN ; IBUPROFEN; METFORMIN ; METOPROLOL ; OZEMPIC; TRAMADOL
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White