MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. DIGITRAK XT HOLTER RECORDER W/LEADWIRES; ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)

Model Number DIGITRAK XT

Device Problem Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2019

Event Type  malfunction  

Event Description

24 hour holter monitor was applied to the patient.Before patient left the office, name and ecg tracings were recording as usual.Upon holter return and downloading, no ecg tracings were noted on the monitor.

• Brand Name: DIGITRAK XT HOLTER RECORDER W/LEADWIRES
• Type of Device: ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS, INC.; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 8522209
• MDR Text Key: 142203927
• Report Number: 8522209
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DIGITRAK XT
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1