MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ PRECISION¿ SOFTWARE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H702496

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

Related manufacturing ref: 2184149-2021-00375.During the case study, the system crashed, and the amplifier led turned amber.The system and amplifier were power cycled.When the amplifier came back up, it went to green for a few seconds and them turned amber.The amplifier was restarted no less than five times and waited for the system to reboot between restarts.When the system was rebooted, the amber light would come on, the green light would flash once for a second and the amber light would stay on.The case was then completed using fluoroscopy with no harm to the patient.

Manufacturer Narrative

The returned study data was reviewed which confirmed the reported event was not software related.Based on the information provided to abbott and the investigation performed, the reported failure to start and subsequent procedure delay remains unknown.

• Brand Name: ENSITE¿ PRECISION¿ SOFTWARE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12843151
• MDR Text Key: 281005464
• Report Number: 2184149-2021-00376
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H702496
• Device Catalogue Number: H702496
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER