MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS M8033C 17 IN. TOUCH DISPLAY

Model Number M8033C

Device Problems Image Display Error/Artifact (1304); Smoking (1585)

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

Event Type  malfunction  

Event Description

The customer reported that there was a short circuit in their m8033c display due to an internal power supply defect.A pt was evacuated from the icu due to the smoke coming out of the display.No pt or user harm was reported.

Manufacturer Narrative

Pr# (b)(4).When investigation is completed, a follow up report will be sent to the fda.

• Brand Name: PHILIPS M8033C 17 IN. TOUCH DISPLAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786597844
• MDR Report Key: 4357392
• MDR Text Key: 5199933
• Report Number: 9610816-2014-00320
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K021778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8033C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2009
• 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