MAUDE Adverse Event Report: MEDILYNX MEDILYNX POCKET ECG 4 CARDIAC EVENT MONITOR; DETECTOR AND ALARM, ARRHYTHMIA

Device Problems Unable to Obtain Readings (1516); Wireless Communication Problem (3283)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

Medilynx 30 day cardiac event monitor stopped working.Error message alert "cannot connect to patient" displayed.Patient called 24/7 support via phone and no one answered any of his several phone calls for help.

• Brand Name: MEDILYNX POCKET ECG 4 CARDIAC EVENT MONITOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDILYNX; richardson TX 75080
• MDR Report Key: 17079299
• MDR Text Key: 316756764
• Report Number: MW5118214
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2023

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: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic