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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS Philips ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) Back to Search Results
Model Number 860322
Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
Event Type  malfunction  
Event Description
Phillips holter monitor returned with "defective card 301" showing on screen, unable to download data. Dr. Entered new order for repeat holter monitor since prescribing dr. On paid time off (pto) this week. Pt will be called by receptionist to reschedule at his convenience due to equipment malfunction. Clinical engineering request will be entered.
 
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Brand NamePhilips
Type of DeviceELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
MDR Report Key8682482
MDR Text Key147464899
Report Number8682482
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 06/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number860322
Device Catalogue Number860322
Device Lot Number453564067171
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2019
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer06/10/2019
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?
Type of Device Usage

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