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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DIGITRAK XT ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)

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PHILIPS MEDICAL SYSTEMS DIGITRAK XT ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) Back to Search Results
Device Problems Visual Prompts will not Clear (2281); Date/Time-Related Software Problem (2582); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2020
Event Type  malfunction  
Event Description
Notes from biomed work order: found device error 602 on display, could not clear it with a battery removal reset. Called philips and discovered this was a global error due to the new year, the 602 error is a firmware error related to the device not correctly interpreting the year 2020 and locking up. Philips is aware of the problem and working to create a resolution for it, when that is completed, i will be notified via e-mail. Team was informed all of the digitrak units are no longer functional until the correction is sent out. Manufacturer response for recorders electronic storage data electrocardiography, digitrak xt (per site reporter) our technician has contact philips per case number [redacted]. No further communication has been sent from philips.
 
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Brand NameDIGITRAK XT
Type of DeviceELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key9664395
MDR Text Key177581814
Report Number9664395
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 Biomedical Engineer
Type of Report Initial
Report Date 01/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/06/2020
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer02/04/2020
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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