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

Model Number SMARTVIEW GPRS

Device Problem Power Problem (3010)

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

Event Date 03/21/2017

Event Type  malfunction  

Event Description

Reportedly, if the smartview home monitor is touched or slightly moved it turns off.

Manufacturer Narrative

(b)(4).

Event Description

Reportedly, if the smartview home monitor is touched or slightly moved it turns off.

• Brand Name: SMARTVIEW
• Type of Device: UNKNOWN
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL (SALUGGIA ITALY); 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6486141
• MDR Text Key: 72799790
• Report Number: 1000165971-2017-00296
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/21/2017
• Event Location: Home
• Date Manufacturer Received: 09/22/2017
• 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