MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS TRACEMASTER ECG MANAGEMENT SYSTEM

Model Number 860281

Device Problem Display Difficult to Read (1181)

Patient Problem Death (1802)

Event Date 07/10/2014

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer stated that a patient that died is still recieving ecg's from other patients.The customer confirmed the device (tracemastervue sw) had no contribution to the patient exitus.

Manufacturer Narrative

The customer stated the expired patient was still getting ecg assigned to them.The customer confirmed the device did not contribute to the patient demise.To assist this customer, the implementation of a script checking for patient id field.When there is no patient id result, a client error, value of zero (0) will be returned.The configuration change was implemented for this site for customer satisfaction purposes.The device remains at the customer site and in use.There have been no additional calls from the customer to report the same failure.The customer reported that a patient that passed away in (b)(6) 2014 was still getting reports assigned to the file.This is not a device malfunction.The device is a sw only program that manages ecg reports.There was no allegation the device contributed to the patient death.

• Brand Name: TRACEMASTER ECG MANAGEMENT SYSTEM
• Type of Device: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5370525
• MDR Text Key: 36094816
• Report Number: 1218950-2016-00370
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: K032103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 860281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2011
• 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