MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC20 CARDIOGRAPH

Model Number	860332
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported the screen is frozen.There was no report of any adverse impact to any user or patient.
Additional Manufacturer Narrative
E2; e3: updated submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
Additional Manufacturer Narrative
The manufacturer previously reported information that the screen was frozen.There was no report of harm to the user or patient.Additional information has been received.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: PAGEWRITER TC20 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC20 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7517674
• Report Number: 1218950-2018-04251
• Device Sequence Number: 11188546
• Product Code: DPS
• UDI-Device Identifier: 00884838028784
• UDI-Public: (01)00884838028784
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K113144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/25/2018

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: 860332
• Device Catalogue Number: 860332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018; 04/19/2018; 04/19/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 06/01/2018; 06/28/2023; 07/25/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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