MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; Computer, diagnostic, programmable

Model Number	100014514
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During device preparation for a supraventricular tachycardia procedure, the amplifier would not power up correctly resulting in a cancellation of procedure.It was noted that the amplifier would not boot to green.The amplifier was rebooted multiple times, the power cables and fiber optic cables were replaced, but the issue was not resolved.It was attempted to boot up the amplifier with no other connections other than the power cable, but the amplifier would not boot to green.The patient was on the table and intubated when the issue occurred.The patient had to be extubated and taken off the table.No procedure was performed, and no adverse events occurred.
Additional Manufacturer Narrative
One ensite velocity amplifier was received for evaluation.Based on the information and investigation provided to abbott, the reported event was able to be confirmed by logs review and the root cause was isolated to intermittent functionality of the catheter amplifier board in slot 12 channel 10.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported power up issue were identified.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Common Device Name: Computer, diagnostic, programmable
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19986368
• Report Number: 2184149-2024-00133
• Device Sequence Number: 4376079
• Product Code: DQK
• UDI-Device Identifier: 05414734210713
• UDI-Public: (01)05414734210713(10)10441908
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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
• Operator of Device: Health Professional
• Device Model Number: 100014514
• Device Catalogue Number: 100014514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female