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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH

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PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH Back to Search Results
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.

 
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Brand NamePAGEWRITER 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 Key4495571
MDR Text Key5349662
Report Number1218950-2015-00606
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK080999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User facility,FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/04/2015
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/13/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/04/2015 Patient Sequence Number: 1
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