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

Model Number	SMARTVIEW HOTSPOT PSTN
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the clinic attempted transmission with equipment, the clinic determined the equipment was not operational.The clinic reported "this product does not "pair" with a patient's monitor as it is a ka860 unit".
Additional Manufacturer Narrative
Please refer to the attached investigation report.
Event or Problem Description
It was reported that when the clinic attempted transmission with equipment, the clinic determined the equipment was not operational.The clinic reported "this product does not "pair" with a patient's monitor as it is a ka860 unit".

• Brand Name: SMARTVIEW HOTSPOT
• Common Device Name: UNKNOWN
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; clamart 92140 ; FR 92140
• MDR Report Key: 7233612
• Report Number: 1000165971-2018-00130
• Device Sequence Number: 158016
• Product Code: OSR
• UDI-Device Identifier: 08031527014630
• UDI-Public: (01)08031527014630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: SMARTVIEW HOTSPOT PSTN
• Device Catalogue Number: SMARTVIEW HOTSPOT PSTN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1