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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 Problem Data Problem (3196)
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 having data integrity issues with philips holter monitors via lifewatch services. A patient's cardiology information was merged with another patient, such that the patient was believed to have atrial fibrillation when he did not. The customer is concerned about a data integrity issue and was unable to receive help with a resolution via lifewatch services. Note that as of the time of this report, the correct philips holter product number is not known. Additional information has been requested of the customer. There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient. The patient was given medication that was not needed, but there was no harm to the involved patient.
 
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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 Key6889496
MDR Text Key87629981
Report Number1218950-2017-06580
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 foreign,user facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 09/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2017
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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