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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY SMARTVIEW HOTSPOT; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY SMARTVIEW HOTSPOT; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS Back to Search Results
Model Number SMARTVIEW HOTSPOT PSTN
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2019
Event Type  malfunction  
Event Description
Reportedly, in order to install the subject smartview monitor at home, the patient powered on a 3g adapter and connected it to the telephone network as well as the subject smartview monitor.After powering on the smartview monitor, the light on the 3g adapter which shows 3g transmission status did not flash or blink at all.No change was observed after 10 minutes.The status light of the smartview monitor lights remained in red and it did not become operative.When the 3g adapter was connected to another smartview monitor, normal operation was confirmed in both 3g adapter and smartview monitor.
 
Manufacturer Narrative
D2 corrected.Please refer to the attached analysis report.
 
Event Description
Reportedly, in order to install the subject smartview monitor at home, the patient powered on a 3g adapter and connected it to the telephone network as well as the subject smartview monitor.After powering on the smartview monitor, the light on the 3g adapter which shows 3g transmission status did not flash or blink at all.No change was observed after 10 minutes.The status light of the smartview monitor lights remained in red and it did not become operative.When the 3g adapter was connected to another smartview monitor, normal operation was confirmed in both 3g adapter and smartview monitor.
 
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Brand Name
SMARTVIEW HOTSPOT
Type of Device
PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos 4 avenue réaumur
clamart 92140
FR  92140
MDR Report Key8481858
MDR Text Key140921049
Report Number1000165971-2019-00190
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/08/2019
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 NumberSMARTVIEW HOTSPOT PSTN
Device Catalogue NumberSMARTVIEW HOTSPOT PSTN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/22/2019
Event Location Home
Initial Date Manufacturer Received 03/22/2019
Initial Date FDA Received04/04/2019
Supplement Dates Manufacturer Received06/27/2019
Supplement Dates FDA Received07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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