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

Model Number SPIDERVIEW

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Date 08/20/2021

Event Type  malfunction  

Event Description

Reportedly, the device became hot during the recording and battery leak was then observed.The inside of the device is dirty and damaged by the battery.

Event Description

Reportedly, the device became hot during the recording and battery leak was then observed.The inside of the device is dirty and damaged by the battery.

• 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
• Manufacturer (Section G): ASICA ZAC DE LA MOINERIE 35400 SAINT MALO FRANCE; parc d'affaires noveos; 4 avenue réaumur; clamart, 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos; 4 avenue réaumur; clamart, 92140 ; FR 92140
• MDR Report Key: 12487241
• MDR Text Key: 271887293
• Report Number: 1000165971-2021-00646
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K032466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 09/10/2021
• Date Manufacturer Received: 10/27/2021
• 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