MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC20 CARDIOGRAPH

Model Number 860332

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the screen is frozen.There was no report of any adverse impact to any user or patient.

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.

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
• Type of Device: 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
• MDR Text Key: 108422466
• Report Number: 1218950-2018-04251
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00884838028784
• UDI-Public: (01)00884838028784
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K113144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 04/19/2018; 04/19/2018
• Supplement Dates FDA Received: 06/01/2018; 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1