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

Model Number	CARDIAC WORKSTATION 5000
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed remote service personnel which included communication with the customer and an attempt to obtain data.The results of the analysis were inconclusive as the provided data did not match the event date of february 12, 2026.The product malfunction was unable to be confirmed because the customer did not respond to requests for additional information.A review of the service history for this device shows the problem has not been reported again for this device.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
Philips received a complaint on the cardiac workstation 5000 indicating that the patient heart rate (hr) recorded as high but physically the patient did not have high hr, the device was in clinical use on a patient at the time of the event.No adverse event was reported.

• 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: 24887892
• Report Number: 9610816-2026-100714
• Device Sequence Number: 21290751
• Product Code: DPS
• UDI-Device Identifier: 00884838094826
• UDI-Public: (01)00884838094826
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/15/2026

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 5000
• Device Catalogue Number: 860439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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