MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER; ELECTROCARDIOGRAPH

Model Number	PAGEWRITER TC50 CARDIOGRAPH
Medical Device Problem Codes	Incorrect Measurement (1383); Unable to Obtain Readings (1516)
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
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.Section e: reporting institution phone #: (b)(6).Section e: reporter phone #: (b)(6).
Event or Problem Description
It was reported that ecg was not reading correctly.The device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
The device was returned to philips bench repair.The bench repair technician (brt) found that there was lots of interference and difficulty getting clear connection when using customer's leads/patient interface module (pim)/cable/clips.The brt tested the device with a known good lead/pim/cable, and there were no issues with ecg.The brt swapped the customer's leads with known good leads, and the customer's pim and patient data cable worked well, so the brt determined that the leads need to be replaced.The brt then used the customer's clips on known good leads/pim/cable, and there was lots of interference and difficulty connecting, so the brt identified that the ecg signal issue is caused by consumables (leads 989803151631 and clips 989803166031) as the pim and device were working well.The customer ordered new leads and clips, and the device was returned to the customer site.The brt clarified the issue to mean that there was "lots of interference and difficulty getting clear connection when using customer's leads/pim/cable/clips".This was determined to be a non-reportable issue.The ecg waveform is obviously poor, non-physiological and may display pacer spikes or noise possibly resulting in high or inaccurate measurements because the ecg signal is not optimized and does not represent the patient's rhythm.Clinicians will use additional means to assess patient condition when measurements are suspect.

• 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: 24575052
• Report Number: 1218950-2026-100131
• Device Sequence Number: 10475179
• Product Code: DPS
• UDI-Device Identifier: 00884838026568
• UDI-Public: (01)00884838026568
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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 TC50 CARDIOGRAPH
• Device Catalogue Number: 860310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 04/11/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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