MAUDE Adverse Event Report: MANUFACTURED FOR MICROPORT CRM S.R.L. SMARTTOUCH; PROGRAMMER, PACEMAKER

Model Number SMARTTOUCH TABLET

Device Problem Wireless Communication Problem (3283)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

Reportedly, bluetooth of the smarttouch tablet does not work.It does not recognized any ble device (e.G.Smart ecg, printer).

Event Description

Reportedly, bluetooth of the smarttouch tablet does not work.It does not recognized any ble device (e.G.Smart ecg, printer).

Manufacturer Narrative

Please refer to the attached analysis report.Analysis synthesis: upon reception, the returned smarttouch tablet was tested, and the reported behavior was confirmed, as bluetooth communication was not available.In-depth analysis revealed that the bluetooth adapter was unexpectedly deactivated, which led to the observed difficulties to use ble communication.The subject smarttouch tablet will follow the repair workflow (including a re-ghost and an installation of smartview 3.14) and will be sent back to the field.

• Brand Name: SMARTTOUCH
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MANUFACTURED FOR MICROPORT CRM S.R.L.; parc d'affaires noveos; 4 avenue reaumur; clamart 92140 ; FR 92140
• 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
• MDR Report Key: 17875011
• MDR Text Key: 324963654
• Report Number: 1000165971-2023-00802
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTTOUCH TABLET
• Device Catalogue Number: SMARTTOUCH TABLET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• 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