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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 No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). A follow-up report will be submitted upon completion of the investigation.

 
Event Description

The customer reported the screen is frozen. There was no report of any adverse impact to any user or patient.

 
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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 Key7517674
MDR Text Key108422466
Report Number1218950-2018-04251
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,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number860332
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 Received04/19/2018
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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