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

Model Number H700150

Device Problem Failure to Analyze Signal (1539)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Prior to the procedure the ekg signals would not display on the screen.The recording system and amplifier were power cycled but the issue remained.The patient was already in the procedure room and under local anesthesia when the case was cancelled.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h6.One workmate claris amplifier was received for evaluation.The returned workmate claris amplifier was powered on, but no communication was established with the test standard workmate claris computer.The single board computer (sbc) was temporarily replaced with a known good sbc board and successful communication was established with the test standard workmate claris computer.Using the test standard sbc board, the amplifier was run for few hours and no interrupted or loss of signal was observed.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.

• 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: 10395209
• MDR Text Key: 202508310
• Report Number: 2184149-2020-00122
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: 05415067001504
• 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
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 6207561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 80