MAUDE Adverse Event Report: ALIVECOR KARDIABAND; ELECTROCARDIOGRAPH

Model Number AC-011

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2024

Event Type  Injury  

Event Description

Kardia band failed to record ekg (electrocardiogram).

• Brand Name: KARDIABAND
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): ALIVECOR
• MDR Report Key: 19128048
• MDR Text Key: 340510013
• Report Number: MW5153937
• Device Sequence Number: 1
• Product Code: DPS
• 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: 04/13/2024

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 Operator: Lay User/Patient
• Device Model Number: AC-011
• Device Catalogue Number: AC-011-38-A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Patient Sequence Number: 1
• Treatment: ELIQUIS. ; METOPROLOL.; VITAMINS.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White