MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM GENCONNECT CABLE, FIBEROPTIC, SC/SC 100FT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 42-04659-002

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.

Event Description

During a procedure, the fiber optic cable connecting the ampere to dws was damaged when stepped on during the procedure troubleshooting included attempting to reconnect, switching the connector, and switching the adapter box but the issue did not resolve.There was no replaceable product and the dws could not display the ampere parameters.The procedure was cancelled and there were no patient consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of inspection results for this lot number confirmed that no non-conformances were identified related to the reported event and the product met abbott specifications.

• Brand Name: ENSITE VELOCITY¿ SYSTEM GENCONNECT CABLE, FIBEROPTIC, SC/SC 100FT
• 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: 9406681
• MDR Text Key: 169014898
• Report Number: 2184149-2019-00242
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 42-04659-002
• Device Catalogue Number: 42-04659-002
• Device Lot Number: 6240303
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other