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

Model Number SPIDERFLASH-T

Device Problems Overheating of Device (1437); Improper Chemical Reaction (2952)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2022

Event Type  malfunction  

Event Description

Reportedly, overheating of the external battery occurred.The battery is sent with.

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, overheating of the external battery occurred.The battery is sent with.

Manufacturer Narrative

The analysis conclusion is the following: upon reception, the reported behavior was not reproduced: no overheating problems occurred during the 24h without interruption.Functional tests revealed that the internal battery was not charging properly.However, there is no link suspected with the overheating.Based on the aforementioned observations, the reported overheating most probably resulted from the (defective) external battery used.The device followed the standard repair workflow (including the replacement of the internal battery) and was sent back to the field.

• Brand Name: SPIDERFLASH-T
• Type of Device: ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): ASICA; zac de la moinerie; saint malo 35400 ; FR 35400
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos; 4 avenue réaumur; clamart 92140 ; FR 92140
• MDR Report Key: 13684888
• MDR Text Key: 286733564
• Report Number: 1000165971-2022-00104
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

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: Health Professional
• Device Model Number: SPIDERFLASH-T
• Device Catalogue Number: SPIDERFLASH-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2022
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 03/07/2022
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/24/2022
• 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
• Patient Ethnicity: Non Hispanic