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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS TRACEMASTER ECG MANAGEMENT SYSTEM Back to Search Results
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.
 
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Brand NameTRACEMASTER ECG MANAGEMENT SYSTEM
Type of DeviceNA
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
MDR Report Key5370525
MDR Text Key36094816
Report Number1218950-2016-00370
Device Sequence Number1
Product Code DSH
Combination Product (y/n)N
Reporter Country CodeLU
PMA/PMN Number
K032103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number860281
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 Received01/11/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/26/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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