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

Model Number SMARTVIEW GPRS

Device Problem Component Missing (2306)

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

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

The serial number is currently unknown.

Event Description

It was reported that a patient has received a home monitor system without a us faceplate adapter power.An investigation is required.

Manufacturer Narrative

Please refer to the investigation report.(b)(4).

Event Description

It was reported that a patient has received a home monitor system without a us faceplate adapter power.An investigation is required.

• 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: 6946627
• MDR Text Key: 90239519
• Report Number: 1000165971-2017-00761
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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 GPRS
• Device Catalogue Number: SMARTVIEW GPRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2017
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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