MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY¿ GE CARDIOLAB RECORDCONNECT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H421019
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the typical cti flutter procedure, the ge recording connect was prompting noise.Another recordconnect was brought to the case from another facility and the case was completed.There were no adverse consequences to the patient.However, a procedure delay occurred due to this issue.
Additional Manufacturer Narrative
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 serial number is unknown.Based on the information received, the cause of the reported incident could not be determined. .
Additional Manufacturer Narrative
One ensite velocity¿ ge cardiolab recordconnect was received for analysis.Visual inspection of the returned product indicated signs of wear consistent with clinical use, labeling was legible and correctly oriented.Inspection of the input and output connectors revealed no signs of physical damage to the connector body or electrical contact pins.The electrical test was successfully completed with no electrical noise or open circuits identified.The field reported issue was not confirmed.Based on the information provided to abbott and the investigation performed, the root cause of the reported event cannot be conclusively determined, as no abnormalities were identified.Review of the device history record was not possible as the lot number is unknown.

• Brand Name: ENSITE VELOCITY¿ GE CARDIOLAB RECORDCONNECT
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12567667
• Report Number: 2184149-2021-00285
• Device Sequence Number: 4031795
• Product Code: DQK
• UDI-Device Identifier: 05414734210195
• UDI-Public: 05414734210195
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 02/02/2022

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: H421019
• Device Catalogue Number: H421019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/29/2021; 01/17/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/29/2021; 02/02/2022
• 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: Unknown