MAUDE Adverse Event Report: SMARTVIEW HOTSPOT; UNKNOWN

Model Number SMARTVIEW GPRS

Device Problem Failure to Transmit Record (1521)

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

Event Date 02/04/2016

Event Type  malfunction  

Event Description

It was reported that after a first proper functioning period, no data could be transferred through smartview hotspot from (b)(6) 2016.The smartview hotspot system boots up with orange status.

• Brand Name: SMARTVIEW HOTSPOT
• Type of Device: UNKNOWN
• MDR Report Key: 5526345
• MDR Text Key: 41534845
• Report Number: 1000165971-2016-00171
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• 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
• Distributor Facility Aware Date: 02/29/2016
• Date Manufacturer Received: 02/29/2016
• 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: Initial
• Patient Sequence Number: 1