MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 100014514

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2017

Event Type  malfunction  

Manufacturer Narrative

The reported event of a fire was confirmed.The results of the investigation indicated the cause for the reported event was due to saline ingress involving the ac inlet module.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

During a cardiac ablation procedure using the carto system the abbott amplifier caught on fire at the power supply receptacle during a case.There were no adverse consequences for the patient or the user.

• Brand Name: ENSITE VELOCITY¿ SYSTEM VELOCITY AMPLIFIER
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7209434
• MDR Text Key: 97881548
• Report Number: 2184149-2018-00012
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2018

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
• Device Operator: Health Professional
• Device Model Number: 100014514
• Other Device ID Number: 05414734210713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1