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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 Problems Fire (1245); Noise, Audible (3273)
Patient Problem Electric Shock (2554)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

The customer reported the monitors shut down and there was a loud noise and a flame coming from the power cord when attaching the ekg-device to the wall. The user was holding the handle of the device and got an electric shock to the left hand.

 
Manufacturer Narrative

The user was holding the plug in the wall socket and received a tingling in the fingers, wrist and arm and a slight headache. There was no treatment needed. The injury is not considered serious as no medical intervention was required and there was no permanent impairment. The customer contacted the customer care solution center (ccsc) for trouble shooting. A field service engineer (fse) confirmed that the problem was caused by the wall socket, and is not considered a product malfunction. The fse recommended that the customer replace the network cable, pin module cable and power cord.

 
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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 Key8404112
MDR Text Key138248770
Report Number1218950-2019-01881
Device Sequence Number0
Product Code DPS
Combination Product (Y/N)
Reporter Country CodeFI
PMA/PMN NumberK020708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 03/05/2019
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received03/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL 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 Received03/05/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/20/2012
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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