MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH CARDIAC WORKSTATION; ELECTROCARDIOGRAPH

Model Number	CARDIAC WORKSTATION 7000
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a cardiac workstation 7000 indicating that the pim module is not recording the ecg properly.This was identified during testing/quality control.The device was not in use on a patient at the time of the event, there was no patient involvement.
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included efforts to reproduce the reported issue.The field service engineer (fse) performed troubleshooting using ecg simulation and was able to replicate the problem.Based on the troubleshooting results, it was determined that part number 453665074741 (cw 12l pim support part, aami) required replacement.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a faulty patient interface module (pim).The issue was resolved by replacing the part and the product is back in service.

• Brand Name: CARDIAC WORKSTATION
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 25476801
• Report Number: 9610816-2026-101129
• Device Sequence Number: 18433146
• Product Code: DPS
• UDI-Device Identifier: 00884838094833
• UDI-Public: (01)00884838094833
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K241556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: CARDIAC WORKSTATION 7000
• Device Catalogue Number: 860441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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