MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY SPIDERVIEW; ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)

Model Number SPIDERVIEW

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Date 04/05/2019

Event Type  Injury  

Event Description

The subject holter was sent back for repair, because a burn of the size of the sensor was reportedly observed on the patient's chest.

Event Description

The subject holter was sent back for repair, because a burn of the size of the sensor was reportedly observed on the patient's chest.

Event Description

The subject holter was sent back for repair, because a burn of the size of the sensor was reportedly observed on the patient's chest.

• Brand Name: SPIDERVIEW
• Type of Device: ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
• 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: 8623168
• MDR Text Key: 145973250
• Report Number: 1000165971-2019-00280
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• PMA/PMN Number: K032466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SPIDERVIEW
• Device Catalogue Number: SPIDERVIEW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/26/2019
• Event Location: Hospital
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other