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 Consequences Or Impact To Patient (2199)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.¿ further information was requested but not received.

Event Description

During the procedure, the amplifier did not communicate as expected.Troubleshooting did not resolve the issue, the amplifier beeped continuously and the case was cancelled.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the amplifier serial number was not provided.Based on the information received, the cause of the reported incident communication issue and subsequent cancellation remains unknown.

Manufacturer Narrative

Additional information: one workmate claris amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels had no physical damage.All of the mounting hardware was secured.The returned workmate claris amplifier was powered on but no communication was established with the test computer.The single board computer (sbc) was temporarily replaced with a known good sbc board and successful communication was established.Using the test standard sbc board, the amplifier was run for few hours and no interrupted or loss of 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.Based on the information provided and the investigation performed, the reported event was due to a non-functional 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: 8974100
• MDR Text Key: 156881983
• Report Number: 2184149-2019-00164
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: 05415067001504
• Combination Product (y/n): N
• PMA/PMN Number: K132073
• 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: 12/12/2019

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: 5771555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 10/16/2019; 12/06/2019
• Supplement Dates FDA Received: 10/22/2019; 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other