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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 Problem Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

 
Event Description

Customer reported their system intermittently locks up. Patient involvement is currently unknown. There was no report of patient or user harm.

 
Manufacturer Narrative

The clarified problem description cannot potentially cause patient harm and is not reportable. Investigation concludes this issue is not reportable and a reportable decision was made in error. This investigation will be closed.

 
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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 Key8871414
MDR Text Key153670847
Report Number1218950-2019-05846
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK020708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number860315
Device Catalogue Number860315
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 Received07/29/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/06/2014
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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