MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 09-1463-0120

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abt specifications and procedures.Based on the information received, the cause of the reported incident could not be determined.

Event Description

During the procedure, the amplifier would not boot up and one single continuous beep was heard and the procedure was cancelled.The amplifier was rebooted several times, but the issue remained.There were no adverse consequences to the patient due to the cancellation.

• Brand Name: EP-WORKMATE SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10508714
• MDR Text Key: 206157306
• Report Number: 2184149-2020-00132
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067003119
• UDI-Public: 05415067003119
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K092810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09-1463-0120
• Device Catalogue Number: 09-1463-0120
• Device Lot Number: 5708101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2010
• 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
• Patient Outcome(s): Other