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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC30 CARDIOGRAPH

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PHILIPS MEDICAL SYSTEMS PAGEWRITER TC30 CARDIOGRAPH Back to Search Results
Model Number 860306
Device Problem Fire (1245)
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 battery an cardiograph caught on fire. There was no patient harm or injury reported.

 
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Brand NamePAGEWRITER TC30 CARDIOGRAPH
Type of DevicePAGEWRITER TC30 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 Key10149995
MDR Text Key195364864
Report Number1218950-2020-03426
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number860306
Device Catalogue Number860306
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/27/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/09/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/18/2015
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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