MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY SMARTVIEW; UNKNOWN

Model Number SMARTVIEW PSTN

Device Problem No Device Output (1435)

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

Event Date 12/13/2016

Event Type  malfunction  

Event Description

Reportedly, the subject home monitor could not be paired despite several trials between (b)(6) and (b)(6) 2016.The following sequence of lights was observed when trying to set up the home monitor: flashing heart button then steady red then green light.This patient has had previous home monitor which reportedly worked.The phone line was not changed in between.This home monitor will be returned for analysis.

Event Description

Reportedly, the subject home monitor could not be paired despite several trials between (b)(6) 2016.The following sequence of lights was observed when trying to set up the home monitor: flashing heart button ¿ then steady red ¿ then green light.This patient has had previous home monitor which reportedly worked.The phone line was not changed in between.This home monitor will be returned for analysis.

• Brand Name: SMARTVIEW
• Type of Device: UNKNOWN
• 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: 6236063
• MDR Text Key: 64257228
• Report Number: 1000165971-2017-00025
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SMARTVIEW PSTN
• Device Catalogue Number: SMARTVIEW PSTN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/13/2016
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• 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