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

Model Number H700150

Device Problems Failure to Analyze Signal (1539); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During the procedure, there was no signal, the computer froze and the procedure was cancelled.

Manufacturer Narrative

One workmate claris amplifier was received for evaluation.The amplifier was powered on but no communication was established with the test workmate claris computer.The single board computer (sbc) was temporarily replaced with a known good sbc board and successful communication was established.Using the test sbc board, a basic signal acquisition/quality test which included the surface ecg, baseline, amplitude and stimulus switching were performed and confirmed that the returned amplifier performed within the factory specifications.However, communication and signal were restored when the suspected sbc was reinstalled.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.The reported event was due to an intermittent sbc board.

• 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
• MDR Report Key: 10076950
• MDR Text Key: 191670488
• Report Number: 2184149-2020-00068
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• 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: 6187791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other