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

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.

• Brand Name: PHILIPS
• Type of Device: ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9610707
• MDR Text Key: 175678755
• Report Number: 9610707
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 860322
• Device Catalogue Number: 860322
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2020
• Date Report to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1