MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SIEMENS/DRAEGER SENSIS 10 PIN, SIRECUST; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number C12601

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The cable appeared burnt.This event did not occur during a procedure and there were no adverse patient consequences.The cable was replaced to resolve the issue.

Manufacturer Narrative

Additional information: pma/510k, if follow-up, what type, device evaluated by mfr.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: SIEMENS/DRAEGER SENSIS 10 PIN, SIRECUST
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10650864
• MDR Text Key: 210463446
• Report Number: 2184149-2020-00157
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K123984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C12601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1