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

Model Number H700977

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  Injury  

Event Description

Related manufacturing ref: 2184149-2018-00200.During preparation for an ep ablation procedure, the amplifier would not communicate with the system and the procedure was cancelled.The error message, "command packet contains incorrect parameters" displayed.The error was attempted to be cleared, the settings were changed on the amplifier, the fiber cable and media converter were replaced with no resolution and the procedure was rescheduled.There were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

The reported communication issue could not be confirmed.When the computer powered on, it passed the self-test and successfully booted the software application.A 24-hour communication test was conducted in the investigation using a test amplifier.The communication between the computer and amplifier was established and was stabilized throughout the test with no issues or errors were noted.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 for the communication issue and subsequent procedure cancellation could not be confirmed.

• 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: 8159367
• MDR Text Key: 130168055
• Report Number: 2184149-2018-00201
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• 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
• Report Date: 01/14/2019

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: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 5905314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WORKMATE¿ CLARIS¿ AMPLIFIER; WORKMATE¿ CLARIS¿ AMPLIFIER
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 62