MAUDE Adverse Event Report: BIOTEL / CARDIONET MCOT MOBILE CARDIAC OUTPATIENT TELEMETRY; DETECTOR AND ALARM, ARRHYTHMIA

Model Number BTP-1000S

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)

Patient Problems Skin Discoloration (2074); Anxiety (2328); Sleep Dysfunction (2517)

Event Date 07/15/2019

Event Type  Injury  

Event Description

On july 15, i requested replacement lead pads and was told next day would receive new leads.Received patch instead and was delivered after the date requested leading to marks left on my chest by having the leads in place for too long a period of time due to not having enough.I questioned if the data was recorded.I asked if they also were told by (b)(6) that monitoring would be done while on vacation.Not true.So during the period of monitoring there was no supervision of my heart that could have lead to death during sleep, travel exertion, and missing heartbeats.I have been anxious over the past few weeks due to the amount of pressure to have the monitor and wear.The monitor would not stop beeping leading to insomnia for 3 weeks.Recorded light sleeping with a sleep monitor.I called on august 12 and (b)(6) was not able to take a proper complaint.Read to him from cfr 21 820.198 what was needed for a complaint.On the phone, he said he did not know what it was.I said that he was not taking a complaint then.Also, he did not screen for an incident report.I asked for a supv and (b)(6) did not know what cfr 21 820.198 was and that they could only take the info from their sop.Mgr was in a meeting and would not leave for either (b)(6) or (b)(6).I asked to speak with the mgr at a later date.Also said i was having problems as i do have hypertension and this interaction is not good for not being taken seriously of my complaint.I was not able to make a complaint due to the nature of the people not knowing what a complaint was.They only wanted to take a small amount of info that was limited.Reaction from ekg pads being left on too long.The pads were insufficient for the time period and not delivered as requested and agreed upon.Also, the wrong pads were delivered.The device was not verified during the interaction and the correct pads were not verified by type.No monitoring for the time period.Packaging sent back to the mfr at their request for monitor evaluation.Pictures available upon request from a different location can be sent when and if i requested.Fda safety report id# (b)(4).

• Brand Name: MCOT MOBILE CARDIAC OUTPATIENT TELEMETRY
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BIOTEL / CARDIONET
• MDR Report Key: 8892688
• MDR Text Key: 154469173
• Report Number: MW5088993
• 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: Patient
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/05/2019
• Device Model Number: BTP-1000S
• Device Catalogue Number: 220-0545-01 REV A
• Device Lot Number: 2247790
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 116