MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. BRILLIANCE 64

Model Number 728231

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

The customer reported that after using the load pedal on the multi-function footswitch to position the pt, they have to adjust the pt's vertical position for the procedure.Occasionally when performing this vertical adjustment, the table also moves into the gantry.Philips service confirmed that there was no harm to the pt or operator, and that all motion does cease when the vertical motion button is released.

Manufacturer Narrative

We have not completed our investigation of this event (b)(4).We will file a follow-up mdr at the completion of this investigation.(b)(4).

• Brand Name: BRILLIANCE 64
• 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: 3579284
• MDR Text Key: 15324025
• Report Number: 1525965-2014-00009
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K033326
• 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: 12/17/2013

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: 728231
• Device Catalogue Number: NCTB423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1