MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. BRILLIANCE ICT SP

Model Number 728311

Device Problems Sticking (1597); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

The customer reported that the pt support was moving, un-commanded, in all directions.The field service engineer (fse) confirmed that there were no injuries associated with the event.The fse determined that the customer had spilled contrast on the footswitch causing the buttons to become stuck engaged and cleaned it to resolve the issue.

Manufacturer Narrative

Note: we have completed our investigation of this event.We will file a follow-up mdr at the completion of this investigation.(b)(4).

• Brand Name: BRILLIANCE ICT SP
• 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: 3587458
• MDR Text Key: 4143213
• Report Number: 1525965-2014-00003
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/12/2013

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: 728311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1