• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS STRESSVUE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS STRESSVUE Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRESSVUE
Type of DeviceNA
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 Key7865118
MDR Text Key119944903
Report Number1218950-2018-07268
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK022618
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received09/11/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number860295
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-