MAUDE Adverse Event Report: Philips Medical Systems PageWriter; Electrocardiograph

Model Number	PageWriter TC35 Cardiograph
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction

• 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 ; +1(617)245-5900
• MDR Report Key: 50906316
• Report Number: 1218950-2026-100667
• Device Sequence Number: 14965375
• Product Code: DPS
• UDI-Device Identifier: 00884838094819
• UDI-Public: (01)00884838094819
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K221141
• 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
• Report Date (Section B): 09/25/2026

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 TC35 Cardiograph
• Device Catalogue Number: 860437
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2026
• 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