MAUDE Adverse Event Report: SCHILLER AG (BAAR, SWITZERLAND) ARGUS PB-3000; ARGUS PB-3000 PATIENT DATA MODULE (PDM)

Model Number	3.921033
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Schiller ag provided merge healthcare inc.With a list of all affected argus pb-3000 serial numbers.Merge performed an investigation to identify all affected merge hemo, model rcsv2 systems, and created a consignee list.Merge field service engineers will be going onsite to test the 27 live units and will test the 57 units shipped but pending install at time installation.All defective pb-3000s will be returned to schiller ag.
Event or Problem Description
During merge healthcare incorporated (hartland, wi) internal testing of the merge hemo, model rcsv2 system, it was observed that certain schiller ag argus pb-3000 patient data module (pdm) units triggered an error message (error code: pressure sensor defective) when performing non-invasive blood pressure (nibp) measurements with an initial pressure over 240 mmhg.The problem was further investigated and confirmed by schiller ag (baar, switzerland), the original equipment manufacturer for the pb-3000.The schiller ag (baar, switzerland) argus pb-3000 patient data module (pdm) is a vital signs monitoring device intended to be integrated into merge healthcare incorporated's (hartland, wi) merge hemo, model rcsv2 system.Merge healthcare incorporated (900 walnut ridge drive, hartland, wi, 53029 usa; fei: 1000116130) is the initial importer of the argus pb-3000 pdm.No other components of the merge hemo, model rcsv2 system are affected.Schiller ag (baar, switzerland) has determined that when the inflation pressure is in the high-pressure range (>240 mmhg), the non-invasive blood pressure (nibp) might become non-functional.This may lead to a short delay in delivery of care that could have minor health impact.Schiller ag (baar, switzerland) has determined the root cause of the issue to be an improper adjustment of the secondary pressure sensor during manufacturing of the argus pb-3000 patient data module (pdm).This faulty adjustment may result in a measurement error being detected by the pdm device, leading to the observed error message on the host system (merge hemo, model rcsv2 system) hemo client application software.

• Brand Name: ARGUS PB-3000
• Common Device Name: ARGUS PB-3000 PATIENT DATA MODULE (PDM)
• Manufacturer (Section D): SCHILLER AG (BAAR, SWITZERLAND); altgasse 68; ch-6341; baar, switzerland ; SZ
• Manufacturer (Section G): MERGE HEALTHCARE; 900 walnut ridge dr; hartland WI 53029
• Manufacturer Contact: nadia marchant ; 900 walnut ridge dr; hartland, WI 53029 ; 8446372848
• MDR Report Key: 22779647
• Report Number: 2183926-2025-00017
• Device Sequence Number: 10045552
• Product Code: MHX
• UDI-Device Identifier: 07613365004359
• UDI-Public: (01)07613365004359(11)250213
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K233326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: Other
• Device Model Number: 3.921033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: TO BE PROVIDED IN FOLLOW
• Patient Sequence Number: 1
• Patient Sex: Unknown