MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Death (1802)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

The customer reported that a cardiograph interpreted the ecg incorrectly.The pt expired.

Manufacturer Narrative

(b)(4).A follow up report will be submitted after philips obtains more info concerning this event.

Manufacturer Narrative

The customer reported that a patient ecg was not interpreted correctly, missing a myocardial infarction.Further investigation showed that the patient died 2 days after the customer issue.The issue was investigated by a cross team where it was determined that the device was working within specifications and was an acceptable risk.A computer-interpreted ecg report is not intended to be a substitute for interpretation by a qualified physician.The interpreted ecg is a tool to assist the physician in making a clinical diagnosis in conjunction with the physician¿s knowledge of the patient, the results of the physical examination, and other findings.The algorithm helps to identify problem areas for the physician and saves time for the physician or editing technician who may only need to add, delete, or modify a few statements.The issue was determined to not represent a risk to health.The device currently remains in use.

• Brand Name: PAGEWRITER TC50 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: greg theokas ; 3000 minuteman rd.; andover, MA 01810 ; 9786871501
• MDR Report Key: 4495571
• MDR Text Key: 5349662
• Report Number: 1218950-2015-00606
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K080999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2014
• 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
• Patient Outcome(s): Death