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

Model Number	H700977
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After prepping the patient for an atrial fibrillation procedure, it was noted that the workmate claris monitors of the 48¿¿ table were not showing any signal.Remote troubleshooting was done, but the issue persisted.The procedure was cancelled.The issue was resolved on a different day by replacing the workmate computer.
Additional Manufacturer Narrative
Corrected information: e1.New information received confirmed the event country for this event was chile.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.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.
Additional Manufacturer Narrative
One claris display workstation (dws) z440 was received.Visual inspection revealed the front panel ports, chassis, and labels show wear consistent with use over time.When the dws was placed on the table it was noted that it does not sit flush.The feet were inspected and identified as all present.It was noted that the removable side panel was gapping near the base and the rear of the chassis.It was also noted that the front bezel has physical damage, and does not secure fully.Internal inspection revealed no observable conditions; however it was noted that the serail card was loose (partially disconnected) from the motherboard.This board was reseated prior to powering on.Power was applied to the dws, and the dws appeared to begin to run power-on-self-test (post), but as the video was never recognized, it could not be confirmed.The power button did not allow quick shut off which also is an indication that loading was in process and not still within the early bios (boot) stages.The video card was temporarily replaced using a known good, which did not alleviate this condition.The add on cards (network, dual serial card, and framegrabber) were removed, which did not alleviate the condition isolating the cause to the motherboard.Further testing could not be performed based on the state of the return.The reported event was able to be duplicated by power sequencing.Based on the investigation and information provided to abbott, the reported event was able to be confirmed, and the root cause was attributed to the motherboard.The batch 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23675614
• Report Number: 2184149-2025-00200
• Device Sequence Number: 18593680
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: (01)05415067009777(10)10658364
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2026

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: 10658364
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 01/16/2026; 04/22/2026
• Initial Report FDA Received Date: 11/29/2025
• Supplement Report FDA Received Date: 12/23/2025; 02/15/2026; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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