MAUDE Adverse Event Report: MANUFACTURED FOR MICROPORT CRM S.R.L. SMART MONITOR; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number SMART MONITOR

Device Problem Power Problem (3010)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.Investigation results: at device reception, the subject home monitor was tested and the reported issue was confirmed.The device does not work anymore.Based on the provided event description and the observations made during the expertise, it can be suspected that the power supply connector of the home monitor is damaged.The root cause of this issue could not be determined; however, it could have resulted from the wear of the power supply connector over time or from a mechanical shock.

Event Description

Reportedly, the home monitor does not power up.Even after changing the power supply the device is not functional.

• Brand Name: SMART MONITOR
• Type of Device: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): MANUFACTURED FOR MICROPORT CRM S.R.L.; parc d'affaires noveos; 4 avenue reaumur; clamart 92140 ; FR 92140
• Manufacturer (Section G): EOLANE; bld j. baptiste colbert; combree 49520 ; FR 49520
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos; 4 avenue reaumur; clamart 92140 ; FR 92140
• MDR Report Key: 17843452
• MDR Text Key: 324587248
• Report Number: 1000165971-2023-00780
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMART MONITOR
• Device Catalogue Number: SMART MONITOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic