MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS STRESSVUE

Model Number 860295

Device Problem Fire (1245)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported arc in the dvd burner which caused an electrical fire.There was no patient/user injury reported.

Manufacturer Narrative

The issue was investigated by philips and the returned pcs were evaluated both by philips and hp and the failures appear to be confined to the ¿sata¿ power connectors and cable.No damage to any other part/component was visible.Because this is not a philips product, philips cannot definitively determine a root cause for this issue.Replacement pcs resolved issue.

Event Description

The customer reported arc in the dvd burner which caused an electrical fire.The device was not connected to a patient at the time of the event.There was no patient/user injury reported.

• Brand Name: STRESSVUE
• Type of Device: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7865118
• MDR Text Key: 119944903
• Report Number: 1218950-2018-07268
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1