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

Model Number	H700124
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial flutter ablation procedure, workmate claris stimulator was unable to communicate.The main frame was replaced to resolve the issue.The procedure was cancelled and there were no adverse patient consequences.
Additional Manufacturer Narrative
One workmate¿ claris¿ ep-4¿ cardiac stimulator was received for analysis.Visual inspection of the returned cardiac stimulator indicated all labels are intact, legible and appear to have no physical damage.It was also verified that all internal components were secured, and no physical damage was detected on the chassis exterior.All mounting hardware was secured, and all socketed ic (integrated circuit) components were fully seated.Preliminary voltage measurements were performed which confirmed the returned cardiac stimulator meets the internal hardware specifications.It was also confirmed that the stimulator failed to successfully execute the post (power on self-test) and communicate with the ep-4 touchscreen pc, which confirms the reported issue.Additional testing isolated the single board computer as the root cause of the communication issue.The sbc (single board computer) was temporarily replaced for the purpose of the evaluation and normal communication was restored to the system.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause of the reported communication issue was isolated to abnormal functionality of the microprocessor.

• Brand Name: WORKMATE CLARIS SYSTEM DISPLAY PLUS
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12252297
• Report Number: 2184149-2021-00242
• Device Sequence Number: 3900752
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H700124
• Device Catalogue Number: H700124
• Device Lot Number: 7625343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1