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); Material Too Rigid or Stiff (1544)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2021

Event Type  malfunction  

Event Description

Reportedly, for at least two times with different battery brand (b)(6) and bovie batteries, both alkaline) the device overheated seriously in a way that it was almost impossible to touch.And one of the exam only lasted 18h and the slot of the battery was full of white substance released from the bovie battery (oxidation).With a third brand of battery (energizer), the overheating was not observed (or was at least not as noticeable).This recorder also does not memorize the date, it is difficult to have good impedances and any channel without noise.Hard buttons and color screen are also not appreciated.

Manufacturer Narrative

H6 - one device problem code has been added.E3: was filled (other health-care professional).Please refer to the analysis report.

Event Description

Reportedly, for at least two times with different battery brand (ikea and bovie batteries, both alkaline) the device overheated seriously in a way that it was almost impossible to touch.And one of the exam only lasted 18h and the slot of the battery was full of white substance released from the bovie battery (oxidation).With a third brand of battery (energizer), the overheating was not observed (or was at least not as noticeable).This recorder also does not memorize the date, it is difficult to have good impedances and any channel without noise.Hard buttons and color screen are also not appreciated.

• 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: 12639424
• MDR Text Key: 276845557
• Report Number: 1000165971-2021-00686
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K032466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• 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: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: No
• 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