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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 Problems Computer Operating System Problem (2898); Compatibility Problem (2960)
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 unit sends data to the server incorrectly, causing a mismatch between two patients.The device was in use on a patient.There was no report of patient or user harm.
 
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Brand Name
PAGEWRITER TC30 CARDIOGRAPH
Type of Device
PAGEWRITER 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 Key10165102
MDR Text Key195895989
Report Number1218950-2020-03528
Device Sequence Number1
Product Code DPS
UDI-Device Identifier00884838081123
UDI-Public(01)00884838081123
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K113144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number860306
Device Catalogue Number860306
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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