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

Model Number 860322

Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

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

Event Date 01/02/2020

Event Type  malfunction  

Event Description

Holter monitors all not functional.Error 602.Manufacturer response for holter monitor, digitrak (per site reporter) short out internal battery to reset.

• 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: 9659218
• MDR Text Key: 177376384
• Report Number: 9659218
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860322
• Device Catalogue Number: 860322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1