MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CARDIAC WORKSTATION; ELECTROCARDIOGRAPH

Model Number	CARDIAC WORKSTATION 7000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the device gave inaccurate readings.The device was in use on a patient at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by onsite service personal which included testing.The results of the analysis determined that the mainboard was faulty.Based on the results of the analysis, it was determined that the product has malfunctioned and the cause of the reported problem was a faulty mainboard.The issue was resolved by replacing the mainboard and the product is back in service.

• Brand Name: CARDIAC WORKSTATION
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 24956216
• Report Number: 1218950-2026-100250
• Device Sequence Number: 10315618
• 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,Followup
• Report Date (Section B): 05/07/2026

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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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