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	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the cardiac workstation 7000 indicating that the heart rate is abnormal.It is unknown if the device was in use at time of event, and there was no adverse event reported.
Additional Manufacturer Narrative
E1: reporting institution phone#(b)(6).A philips field service engineer (fse) confirmed the issue and replaced the mainboard, ensured configurations were loaded, and upgraded the software.Testing with a simulator and esa was completed, and the unit was found to be in good working condition.The device was returned to the user to use and monitor.Analysis was performed and investigation has been completed.The engineer replaced the mainboard for the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 25172898
• Report Number: 9610816-2026-100939
• Device Sequence Number: 10199725
• 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): 05/14/2026

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: 04/21/2026
• Initial Report FDA Received Date: 05/14/2026
• 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