MAUDE Adverse Event Report: ST. JUDE MEDICAL EP-WORKMATE AND WORKMATE CLARIS EP-4 TOUCHSCREEN COMPUTER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H21911
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One ep-workmate¿ and workmate¿ claris¿ ep-4¿ touchscreen computer was received into the lab for analysis.No original packaging was available for inspection.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.The touchscreen pc produced an audible tone when connected to the external power supply, as indication of a successful hardware self-test.It was also verified that the touchscreen pc did not exhibit noticeable delay or unexpected errors during the serial communication test.All pacing protocols were tested for functionality and no abnormalities were identified.The actual pacing protocol in use, sensory input, automatic synch function and desired cycle length were not communicated and remain undetermined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No rework or non-conformances associated with the reported event were identified.Per the event description, the unintended pacing was due to user error.
Event or Problem Description
During the procedure, the ep-4 stimulator started to pace and was thought to have induced the patient into ventricular fibrillation due to the issue.The unintended stimulation was able to be stopped once it was discovered and defibrillation was used to restore the patient into sinus rhythm.The induction of the ventricular fibrillation was noted to have been caused by the user and an improper workflow of the device and there was no performance issue with the device.Further information on the event is unavailable despite attempts to gather the information.

• Brand Name: EP-WORKMATE AND WORKMATE CLARIS EP-4 TOUCHSCREEN COMPUTER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 12518050
• Report Number: 2184149-2021-00278
• Device Sequence Number: 5122515
• Product Code: DQK
• UDI-Device Identifier: 05414734219112
• UDI-Public: 05414734219112
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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
• Operator of Device: Health Professional
• Device Model Number: H21911
• Device Catalogue Number: H21911
• Device Lot Number: 6448872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention