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

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.

• Brand Name: Philips
• Type of Device: ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 8682482
• MDR Text Key: 147464899
• Report Number: 8682482
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 860322
• Device Catalogue Number: 860322
• Device Lot Number: 453564067171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/10/2019
• Type of Device Usage: N
• Patient Sequence Number: 1