MAUDE Adverse Event Report: ABBOTT MEDICAL WORKMATE¿ CLARIS¿ COMPUTER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700977
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an avnrt procedure, electrical issues resulted in the procedure being cancelled.It was noted that the computer would not boot up, believed to be related to a bitlocker issue.No encryption key was available until the following day so the procedure was postponed.The computer was replaced which resolved the issue and the procedure was completed the next day with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One claris display workstation (dws) z440 was received for evaluation.The reported event was not able to be confirmed.The event description was related to the missing (or non-returned) parts.Based on the investigation and information provided to abbott, the reported event was not able to be duplicated, and the root cause remains undetermined as the affected materials were not returned.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.

• Brand Name: WORKMATE¿ CLARIS¿ COMPUTER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22301615
• Report Number: 2184149-2025-00118
• Device Sequence Number: 12946233
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: (01)05415067009777(10)10134708
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K210392
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: H700977
• Device Catalogue Number: H700977
• Device Lot Number: 10134708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown