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.

• 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
• 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: FOREIGN,USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/16/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 860332
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/19/2018
• 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