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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 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 ajmaline 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.

 
Event Description

The customer reported that during a timed ecg sequence, which was being used for an ajmaline study, the ecg machine froze. The machine stopped printing ecg and would not respond to interaction. The device was in use on a patient and there was no adverse event.

 
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Brand NamePAGEWRITER TC50 CARDIOGRAPH
Type of DevicePAGEWRITER TC50 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 Key6961640
MDR Text Key89989688
Report Number1218950-2017-07275
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK080999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/19/2017
Is This An Adverse Event Report? No
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? No
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/02/2017
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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