MAUDE Adverse Event Report: MICROPORT CRM S.R.L. GALI DF1 SONR CRT-D 2811; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION

Model Number GALI DF1 SONR CRT-D 2811

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

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

Event Date 10/04/2022

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.

Event Description

Reportedly, the date/hour of tests are printed incorrectly, whereas they are correctly displayed on the programmer.

Event Description

Reportedly, the date/hour of tests are printed incorrectly, whereas they are correctly displayed on the programmer.Second occurrence of the problem on another device.

Manufacturer Narrative

Data analysis showed the raat and lvat start time values are not printed in the correct format.When printing raat or lvat start time, the printing value is ¿&xxat_1h¿ instead of ¿1:00¿ or ¿&xxat_2h¿ instead of ¿2:00¿.This issue occurs in direct print and in the report printing.- corrective actions of this software issue are currently being contemplated.

• Brand Name: GALI DF1 SONR CRT-D 2811
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
• 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
• MDR Report Key: 15637529
• MDR Text Key: 302834658
• Report Number: 1000165971-2022-00458
• Device Sequence Number: 1
• Product Code: NIK
• 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,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GALI DF1 SONR CRT-D 2811
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic