• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS PHILIPS ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) Back to Search Results
Model Number 860322
Device Problem Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2020
Event Type  No Answer Provided  
Event Description
Philips has determined that an issue with the firmware results in abnormal device behavior associated with the recorder's internal real-time clock. This manifests itself when the year rolls over from 2019 to 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePHILIPS
Type of DeviceELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key9610707
MDR Text Key175678755
Report Number9610707
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 01/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number860322
Device Catalogue Number860322
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 FDA01/08/2020
Event Location No Information
Date Report to Manufacturer01/21/2020
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

-
-