MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2

Model Number PARADYM 2 DR 8552

Device Problem Reset Problem (3019)

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

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

It was reported that the subject device was found on nominal settings and had experienced 3 resets.According to preliminary analysis results, a device hardware issue was suspected.Patient care recommendations were provided (evaluation of the benefit of device replacement).

Manufacturer Narrative

It was reported that the subject device was replaced on (b)(6) 2016.It was returned for analysis.

Event Description

It was reported that the subject device was found on nominal settings and had experienced 3 resets.According to preliminary analysis results, a device hardware issue was suspected.Patient care recommendations were provided (evaluation of the benefit of device replacement).

Event Description

It was reported that the subject device was found on nominal settings and had experienced 3 resets.According to preliminary analysis results, a device hardware issue was suspected.Patient care recommendations were provided (evaluation of the benefit of device replacement).

• Brand Name: PARADYM 2
• 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): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; 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: 5972729
• MDR Text Key: 55801699
• Report Number: 1000165971-2016-00574
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: PARADYM 2 DR 8552
• Device Catalogue Number: PARADYM 2 DR 8552
• Device Lot Number: 2856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/16/2016
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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