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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TOUCH CARDIOGRAPH PAGEWRITER TC70 CARDIOGRAPH
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PHILIPS MEDICAL SYSTEMS PAGEWRITER TOUCH CARDIOGRAPH PAGEWRITER TC70 CARDIOGRAPH Back to Search Results
Model Number 860315
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

 
Event Description

The customer reported that during a timed ecg sequence, which was being used for an (b)(6) study, the ecg machine froze. The machine stopped printing ecg and would not respond to interaction. There was no report of a death or serious injury in association with this event.

 
Manufacturer Narrative

 
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Brand NamePAGEWRITER TOUCH CARDIOGRAPH
Type of DevicePAGEWRITER TC70 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 Key7012695
MDR Text Key92216465
Report Number1218950-2017-07645
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK020708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number860315
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/20/2017
Was Device Evaluated By Manufacturer? Yes
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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