MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 09-1462-0056

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  Injury  

Event Description

Prior to the procedure, the amplifier was emitting a beeping tone that could not be resolved and the procedure was cancelled.Troubleshooting was attempted with no resolution and the procedure was rescheduled.The patient was not prepared but was in the room at the time of cancellation.There were no adverse consequences to the patient.

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 abbott specifications and procedures.Based on the information received, the cause of the reported self test issue and subsequent procedure cancellation could not be determined.

Manufacturer Narrative

Additional information: the reported complaint of loss of communication was confirmed.As received, the returned ep-workmate scu powered on but no communication was established due to an unseated single board computer (sbc) board.The displaced board was properly seated and successful communication was restored.The communication test was run for several hours and no interrupted or loss of communication was observed.The reported communication issue and subsequent procedure cancellation was due to the unseated single board computer (sbc).

• Brand Name: EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8191304
• MDR Text Key: 131211072
• Report Number: 2184149-2018-00209
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067003126
• UDI-Public: 05415067003126
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 09-1462-0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other