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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. DIGITRAK XT HOLTER RECORDER W/LEADWIRES ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)

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PHILIPS MEDICAL SYSTEMS, INC. DIGITRAK XT HOLTER RECORDER W/LEADWIRES ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) Back to Search Results
Model Number DIGITRAK XT
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2019
Event Type  malfunction  
Event Description
24 hour holter monitor was applied to the patient. Before patient left the office, name and ecg tracings were recording as usual. Upon holter return and downloading, no ecg tracings were noted on the monitor.
 
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Brand NameDIGITRAK XT HOLTER RECORDER W/LEADWIRES
Type of DeviceELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS, INC.
3000 minuteman rd
andover MA 01810
MDR Report Key8522209
MDR Text Key142203927
Report Number8522209
Device Sequence Number1
Product Code MWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/17/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDIGITRAK XT
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/02/2019
Event Location Hospital
Date Report to Manufacturer04/17/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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