MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC30 CARDIOGRAPH

Model Number	860306
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
Customer reported the unit sends data to the server incorrectly, causing a mismatch between two patients.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: PAGEWRITER TC30 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC30 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10165102
• Report Number: 1218950-2020-03528
• Device Sequence Number: 14109702
• Product Code: DPS
• UDI-Device Identifier: 00884838081123
• UDI-Public: (01)00884838081123
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K113144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 860306
• Device Catalogue Number: 860306
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1