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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC20 CARDIOGRAPH

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PHILIPS MEDICAL SYSTEMS PAGEWRITER TC20 CARDIOGRAPH Back to Search Results
Model Number 860332
Device Problem Data Problem (3196)
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 the unit sends data to the server incorrectly, causing a mismatch between two patients. The device was in use on a patient. There was no report of patient or user harm.

 
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Brand NamePAGEWRITER TC20 CARDIOGRAPH
Type of DevicePAGEWRITER TC20 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 Key10163943
MDR Text Key196057337
Report Number1218950-2020-03525
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK113144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number860332
Device Catalogue Number860332
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 Received06/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/25/2017
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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