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

Model Number H700169

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Prior to the procedure with the patient prepped, there was no communication between the amplifier and the computer.All of the connection cables were checked, and the optical fiber and converter were replaced, but the issue remained and the case was cancelled.

Manufacturer Narrative

One workmate claris amplifier was received for evaluation.The returned 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 were performed using a test media converter and noise artifact was observed on channel 2.The filter card was temporarily replaced and no noise artifact was observed.The communication test was run for over 40 hours and no loss or interrupted communication was observed.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 results of investigation revealed the amplifier was powered on and successful communication was established.The cause for the reported communication issue remains unknown.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM 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: 9008992
• MDR Text Key: 157833261
• Report Number: 2184149-2019-00166
• Device Sequence Number: 1
• Product Code: DQK
• 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
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other