MAUDE Adverse Event Report: ST. JUDE MEDICAL CARDIAC BIOSENS / ST. JUDE MEDICAL; EP WORKMATE

Model Number 56 CHANNEL AMP

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2014

Event Type  malfunction  

Event Description

Electrophysiology case had started; pt had conscious sedation administered; catheters were placed in the heart via percutaneous venous insertion and the ep equipment didn't work.Per op report: the ep workmate showed an error signal.Multiple attempts were made to troubleshoot ep workmate, including the st jude technicians in (b)(4) as well as st jude technical service.Add'l, biomed services came down to the cath lab.The problem was isolated most likely to the amplifier.Case was abandoned, no procedure performed.Case has been rescheduled for another date.

• Brand Name: BIOSENS / ST. JUDE MEDICAL
• Type of Device: EP WORKMATE
• Manufacturer (Section D): ST. JUDE MEDICAL CARDIAC; 15900 valley view ct; slymar CA 91342 922
• MDR Report Key: 4270072
• MDR Text Key: 5005460
• Report Number: MW5039139
• Device Sequence Number: 1
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 56 CHANNEL AMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 64