MAUDE Adverse Event Report: ALIVECOR KARDIAMOBILE; TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Device Problems Product Quality Problem (1506); Inadequate Instructions for Non-Healthcare Professional (2956); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/09/2022

Event Type  malfunction  

Event Description

I purchased kardiamobile from alivecor and was unable to get the product to operate properly.I telephoned support and reached someone located outside the u.S.My request to speak with a support person inside the u.S.Was denied.The product instructions are confusing and the product does not operate or function as promised in product advertising.I have asked for a full refund.Fda safety report id# (b)(4).

• Brand Name: KARDIAMOBILE
• Type of Device: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Manufacturer (Section D): ALIVECOR
• MDR Report Key: 15596604
• MDR Text Key: 301859108
• Report Number: MW5112593
• Device Sequence Number: 1
• Product Code: DXH
• 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: 10/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White