MAUDE Adverse Event Report: PHILIPS PHILIPS BRILLIANCE 16; CT MACHINE

Device Problems Smoking (1585); Noise, Audible (3273)

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

Event Date 10/08/2014

Event Type  malfunction  

Event Description

The ct machine b ((b)(6)) began to smoke and "cracking and popping' noises, along with electrical shell following a power outage in building.Repaired by philips and returned to facility.

• Brand Name: PHILIPS BRILLIANCE 16
• Type of Device: CT MACHINE
• Manufacturer (Section D): PHILIPS; andover MA
• MDR Report Key: 4387102
• MDR Text Key: 5302600
• Report Number: MW5039948
• Device Sequence Number: 1
• Product Code: JAK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1