MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY CPR3; PROGRAMMER, PACEMAKER

Model Number CPR3

Device Problems Telemetry Discrepancy (1629); Device Operates Differently Than Expected (2913); Operating System Becomes Nonfunctional (2996); Interrogation Problem (4017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2018

Event Type  malfunction  

Event Description

It was reported that the subject cpr3 head did not initialize.Preliminary analysis revealed that the reported issue is due to a damaged conductor wire on the cpr3 head.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

It was reported that the subject cpr3 head did not initialize.Preliminary analysis revealed that the reported issue is due to a damaged conductor wire on the cpr3 head.

• Brand Name: CPR3
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FRANCE; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 7653248
• MDR Text Key: 112846808
• Report Number: 1000165971-2018-00631
• Device Sequence Number: 0
• Product Code: KRG
• Reporter Country Code: US
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CPR3
• Device Catalogue Number: CPR3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2018
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 07/26/2018
• 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: Reuse
• Patient Sequence Number: 1