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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 No Device Output (1435); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

 
Event Description

The customer reported audio failed on their tc70 device. It was confirmed that the device had no sound and failed audio test. There was no patient injury/harm reported.

 
Event Description

The customer reported audio failed on their tc70 device. It was confirmed that the device had no sound and failed audio test. The device was not in clinical use at the time of the event. No patient involvement.

 
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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 Key7283549
MDR Text Key100560593
Report Number1218950-2018-01965
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/20/2018
Is This An Adverse Event Report? No
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/30/2012
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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