MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. BRILLIANCE 6 AIR

Model Number 728256

Device Problem Unintended Movement (3026)

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

Event Type  No Answer Provided  

Event Description

The philips field service engineer was performing service on a ct system at the customer's site and was informed by the customer that on another philips ct system when the down button is pushed the couch would travel downward past the lowest design limit and come in contact with the gantry.There was no report of harm to a pt or operator.

Manufacturer Narrative

We have not completed our investigation of this event (b)(4).We will file a f/u mdr at the completion of the investigation.(b)(4).

• Brand Name: BRILLIANCE 6 AIR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd.; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 3644771
• MDR Text Key: 4348605
• Report Number: 1525965-2014-00024
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K012009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 728256
• Device Catalogue Number: NCTA396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 02/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1