MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE CLARIS SYSTEM COMPUTER Z620; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700977

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the procedure, the error "command packet error contains incorrect parameters" displayed and the procedure was cancelled.The fiber optic cable was replaced with no resolution.All lights appeared green and the media converter was connected properly.The system was power-cycled after clearing the error message with no resolution.While troubleshooting the amplifier signal sampling rate, the stimulator marker time was grayed out as if the amplifier was not connected.A communication test was performed and the unit was communicating with the amplifier.An amplifier error stating "command contain incorrect parameters" displayed so the error message was cleared and the unit was restarted.The error message disappeared but reappeared after a few seconds.A second amplifier was attempted but the error displayed so the procedure was cancelled.There were no adverse consequences to the patient due to the cancellation.Further troubleshooting determined the claris was pushed too far to the left on the pc rack causing tension on the fiber optic and cat-5 cabling, causing the communication issues.Once the tension on the cables was removed, the errors were resolved and the system functioned as intended.

Manufacturer Narrative

Further troubleshooting in the field determined the claris was pushed too far to the left on the pc rack causing tension on the fiber optic and cat-5 cabling, causing the communication issues.Once the tension on the cables was removed, the errors were resolved and the system functioned as intended.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.The cause of the communication issue and subsequent procedure cancellation was due to tension on the cabling connecting to the unit.

• Brand Name: WORKMATE CLARIS SYSTEM COMPUTER Z620
• 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: 9377774
• MDR Text Key: 168244347
• Report Number: 2184149-2019-00235
• 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
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 6876798
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other