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

Model Number SMARTTOUCH TABLET

Device Problem Computer Software Problem (1112)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

Reportedly, an error occurs, indicating an issue during program initialization, when starting the smarttouch tablet.Since 25 october the issue occurred sporadically, but became more frequent with the time and also occurred during switching between the tabs.Additionally to that, the smarttouch tablet cannot be connected to the ble printer anymore.

Manufacturer Narrative

-upon reception, the returned smarttouch tablet was tested, and the reported behaviors were confirmed, as bluetooth communication was not available with the printer.- in-depth analysis revealed that the bluetooth adapter was unexpectedly deactivated, which led to the observed difficulties to use ble communication with a printer.This could also explained the displayed error message.- it should be noted that a correction of this software issue has been implemented in smartview 3.14.- the subject smarttouch tablet will follow the repair workflow (including an installation of smartview 3.14) and will be sent back to the field.

Event Description

Reportedly, an error occurs, indicating an issue during program initialization, when starting the smarttouch tablet.Since (b)(6) the issue occurred sporadically, but became more frequent with the time and also occurred during switching between the tabs.Additionally to that, the smarttouch tablet cannot be connected to the ble printer anymore.

• Brand Name: SMARTTOUCH
• Type of Device: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 18275212
• MDR Text Key: 329931900
• Report Number: 1000165971-2023-01007
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTTOUCH TABLET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2024
• 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