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

Model Number	H700150
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a wolff-parkinson-white procedure, the amplifier and media converter were having communication issues that resulted in a cancellation of procedure.After the patient was connected to the workmate claris ecg, but before vein puncture, a 12 lead ecg had a slow drawing speed on the live screen of the workmate claris system.The 200mm/sec looked like 50mm/sec.The drawing speed was able to be manually changed, but still appeared slower than usual.The 400mm/sec looked like normal speed.Additionally, the r-r interval defined during setup measured every qrs as it should, but the interval was shorter (about 250ms =240bpm) than the patient¿s actual heart rate 80bpm (about 750ms).The heart rate was also being measured on the non-abbott (phillips) monitor.Changing the speed did not affect the r-r interval.Changing the cathmaps or leads where the r-r interval was measured did not resolve the issue.Restarting the system multiple times and checking all settings, including the ini settings file, did not resolve the issue.The workmate claris cpu is z440 and claris sw version is 1.3.1.The site had spare cpu z440 with claris sw version 1.1.1, which was swapped to see whether the issue persisted and it did.It was noted that drawing speed of the ecg was normal prior to the workmate claris connecting to the amplifier.Right after connection was completed, the drawing speed slowed down to the level described above.The r-r interval was not shown during the connection phase, so that could not be confirmed.With demo signals everything worked like it should.The issue was seen only on the live patient ecg.Previous procedure data was shown as it should from previous days, r-r interval included.The fiber between the workmate claris cpu and amplifier, and ecg cables were changed, but did not resolve the issue.The fiber to rj-45 converter or another amplifier could not be tested as there was not a spare available.The workmate claris screen resolution was checked as well and had not changed from 1920x1080.A new amplifier and converter have been ordered in hopes of resolving the issue.The procedure was rescheduled and all procedures in that lab had been rescheduled.Later, the replacement amplifier and new rj-45/fiber converter were received, and the issue was resolved.
Additional Manufacturer Narrative
One workmate claris amplifier 120 channels was received for evaluation.The amplifier was functioning as intended during investigation.Based on the information and investigation provided to abbott, the root cause remains undetermined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the communication issue were identified.

• Brand Name: WORKMATE¿ CLARIS¿ AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE 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: 20036727
• Report Number: 2184149-2024-00140
• Device Sequence Number: 12389063
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: (01)05415067001504(10)5256604
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 10/24/2024

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: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 5256604
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WORKMATE CLARIS MEDIA CONVERTER
• Patient Sex: Unknown