MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. STRESSVUE STRESS TESTING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number SK963UC#ABA

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)

Patient Problem No Information (3190)

Event Date 08/19/2018

Event Type  malfunction  

Event Description

A few minutes after turning on the computer system of the stressvue system from philips, someone smelled something burning.They saw smoke coming from the computer and immediately pulled the power cord out and called the fire department.Computer was doused with water by the fire department and it personnel removed it to their area.On exam the connection cable to the dvd writer was melted and so was the back end of the writer.This happened again a second time with an additional unit computer (b)(4) with dvd model hp dh-16ablh-hh2 with sn (b)(4) with burns in the same location.To prevent anything from happening to the third unit the dvd writer was unplugged.

• Brand Name: STRESSVUE STRESS TESTING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS, INC.; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 7893286
• MDR Text Key: 120855120
• Report Number: 7893286
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SK963UC#ABA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1