MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY SYSTEM CABLE, FIBEROPTIC, SC/SC 50 FT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 42-04659-001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the procedure, the optical fiber line connecting the mainframe computer to the amplifier was broken and the signal could not be connected.A cable from another hospital was used, causing a clinically significant delay to the procedure.The procedure was able to be completed with no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was unable to be reviewed since the batch/serial number(s) is unknown.

• Brand Name: ENSITE VELOCITY SYSTEM CABLE, FIBEROPTIC, SC/SC 50 FT
• 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: 10127768
• MDR Text Key: 194305350
• Report Number: 2184149-2020-00074
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 42-04659-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2020
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other