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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DIGITRAK XT HOLTER RECORDER DIGITRAX XT HOLTER RECORDER

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PHILIPS MEDICAL SYSTEMS DIGITRAK XT HOLTER RECORDER DIGITRAX XT HOLTER RECORDER Back to Search Results
Model Number 860322
Device Problems Break (1069); Fire (1245); Melted (1385); Smoking (1585)
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 completed.
 
Event Description
The customer reported that when plugging recorder in docking station it caught fire and damaged the dtxt recorder. There was no patient injury /harm reported. The customer verified that there was smoldering smoke and the plug was burnt and melted.
 
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Brand NameDIGITRAK XT HOLTER RECORDER
Type of DeviceDIGITRAX XT HOLTER RECORDER
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
nancy ataide
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6363859
MDR Text Key68803316
Report Number1218950-2017-01354
Device Sequence Number1
Product Code MWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993617
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number860322
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 Received02/07/2017
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

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