MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY INTEGRAL PROCESS HOLTER CABLES; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number INTEGRAL PROCESS HOLTER CABLES

Device Problems Device Damaged Prior to Use (2284); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2018

Event Type  malfunction  

Event Description

It was reported that the new holter cable was found damage on the blue electrode wire.The outer layer shows a small and deep cut.

Event Description

It was reported that the new holter cable was found damage on the blue electrode wire.The outer layer shows a small and deep cut.

• Brand Name: INTEGRAL PROCESS HOLTER CABLES
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 7512859
• MDR Text Key: 108618346
• Report Number: 1000165971-2018-00486
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

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: INTEGRAL PROCESS HOLTER CABLES
• Device Catalogue Number: INTEGRAL PROCESS HOLTER CABLES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/07/2018
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 08/10/2018
• Patient Sequence Number: 1