MAUDE Adverse Event Report: MICROPORT CRM S.R.L. SMARTTOUCH; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number SMARTTOUCH SOFTWARES MODULES

Device Problem Wireless Communication Problem (3283)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

Reportedly, the bluetooth communication does not function as it cannot detect printer and smart ecg devices.

Event Description

Reportedly, the bluetooth communication does not function as it cannot detect printer and smart ecg devices.

Manufacturer Narrative

The review of provided data highlighted an issue coming with the bluetooth low energy (ble) card on (b)(6) 2023.On (b)(6) 2023, the smartview software version was 3.12.The ble function has been improved in the software smartview 3.14.Re-ghost and installation of the smartview 3.14 are recommended.No other malfunction is suspected on the device.The tablet will follow the repair process to perform the re-ghost and the smartview 3.14 installation before being sent to the requester.This case is retained and utilized for trend purposes.

• Brand Name: SMARTTOUCH
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• 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: 17815417
• MDR Text Key: 324215460
• Report Number: 1000165971-2023-00770
• Device Sequence Number: 1
• Product Code: MRM
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTTOUCH SOFTWARES MODULES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2023
• 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