MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC30 CARDIOGRAPH

Model Number 860306

Device Problem Data Problem (3196)

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

Event Type  Malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event 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
• Type of Device: PAGEWRITER TC30 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: 10164614
• MDR Text Key: 196060141
• Report Number: 1218950-2020-03527
• 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,HEALTH PROFESSIONAL,U
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/17/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 860306
• Device Catalogue Number: 860306
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 11/04/2010
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse