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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
It was reported that a patient death occurred.The customer has not alleged a product failure but is requesting technical support with interpretation of a patients qtc data.
 
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Brand Name
PAGEWRITER TOUCH CARDIOGRAPH
Type of Device
PAGEWRITER TC70 CARDIOGRAPH
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
wendy chadbourne
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6230417
MDR Text Key64081467
Report Number1218950-2017-00068
Device Sequence Number1
Product Code DPS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Caregivers
Device Model Number860315
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2016
Initial Date FDA Received01/06/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/26/2017
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
Patient Sequence Number1
Patient Outcome(s) Death; Other;
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