MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER; ELECTROCARDIOGRAPH

Model Number	PAGEWRITER TC70 CARDIOGRAPH
Medical Device Problem Codes	Incorrect Measurement (1383); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tc70 monitor was displaying erroneous information, specifically a persistent atrial fibrillation (a-fib) reading on patients who were subsequently clinically assessed and confirmed not to have a-fib.There was no adverse event reported.
Additional Manufacturer Narrative
A philips field service engineer (fse) visited the customer site to evaluate the device.Functional testing was performed using an ecg simulator.The assessment did not identify any mechanical issues, and all patient leads were confirmed to be operating correctly.Philips has requested additional information from the customer to support further investigation.At this time, the complaint remains under investigation.A final report will be issued upon completion of the investigation and once all relevant information has been reviewed.
Additional Manufacturer Narrative
Follow-up investigation activities were conducted for the reported event.A philips technical consultant (tc) performed a second onsite visit on april 21, 2026.Upon arrival, the biomedical engineer reported that the device had been functioning properly since the previous philips onsite visit conducted on april 3, 2026.The tc performed additional functional testing utilizing an ecg simulator.No device malfunction or mechanical abnormalities were identified during the evaluation, and all patient leads were verified to be functioning as intended.Additional event details and patient strips were requested to support the investigation; however, no further information was made available by the customer.At this time, the investigation remains ongoing.Philips is continuing efforts to obtain additional information relevant to the reported event.A supplemental/final report will be submitted upon completion of the investigation.

• Brand Name: PAGEWRITER
• 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: 24850630
• Report Number: 1218950-2026-100221
• Device Sequence Number: 5624084
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: (01)00884838026582
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2026

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: PAGEWRITER TC70 CARDIOGRAPH
• Device Catalogue Number: 860315
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 06/17/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/19/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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