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 01/31/2023

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.Analysis conclusion: expertise of the subject home monitor confirmed the reported behavior and revealed that the power supply connector was broken.The root cause of this issue could not be determined; however, it could result from the wear of that component or from a mechanical shock.

Event Description

Reportedly, the power connector of the home monitor is damaged as the status light only lights up when holding the cable.

• 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: 16465827
• MDR Text Key: 310496876
• Report Number: 1000165971-2023-00118
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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: 02/10/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2023
• 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