MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700150

Device Problem Communication or Transmission Problem (2896)

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

Event Date 09/14/2021

Event Type  malfunction  

Event Description

During an supraventricular tachycardia (svt) procedure, the claris booted up and showing all ecgs and intracardiac signals.Suddenly it showed an ¿amplifier disconnected¿ error and lost all signals.Clicking on ¿amplifier disconnected¿ showed the ¿clear error¿ option as being greyed out.The whole system was restarted and it worked for about 20 minutes before doing the same thing again.A different fo cable was used but this didn't reconnect the amplifier.The media converters were exchanged a few weeks ago.The issue occurred three times throughout the procedure, but the procedure was still able to be completed with no adverse patient consequences.A procedure delay occurred due to this issue.

Manufacturer Narrative

One workmate claris amplifier with pn 100084421 and sn (b)(6) was received for evaluation.The returned workmate claris amplifier was powered on and successful communication was established with the test standard workmate claris computer.A basic signal acquisition/quality test which included the surface ecg, baseline, amplitude, and stimulus switching was performed and confirmed that the returned amplifier performed within the specifications.The communication test was run for over 19 hours and no interruption or drop in communication was observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER
• 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: 12664767
• MDR Text Key: 277376911
• Report Number: 2184149-2021-00306
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: 05415067001504
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 6090008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1