MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 16

Model Number 728245

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer reported that while in the process of starting a patient procedure, with the patient sitting on the patient support, the patient support fell in the downward vertical direction 15cm.Philips service confirmed there was no harm to a patient, operator or bystander as a result of the reported event.The philips field service engineer instructed the customer to not use the system until it was evaluated.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).On 27-feb-2014, the customer reported that while in the process of starting a patient procedure, with the patient sitting on the patient support, the patient support fell in the downward vertical direction.The customer contacted the philips help desk to inform them of the issue and a field service engineer (fse) was dispatched to the site.Philips service confirmed there was no harm to a patient, operator or bystander as a result of the reported event.The philips field service engineer instructed the customer to not use the system until it was evaluated.On 28-feb-2014, the fse arrived on site and evaluated the system.Upon evaluation, the fse confirmed with the customer that the couch did not fall down as had been reported.Only the telescoping covers fell down.The customer then lowered the couch to the lowest position for positioning a patient, causing the covers to come into contact with the patient support and break at the corners.No rescan was required.The fse verified that the vertical brake was working properly.The fse replaced all of the patient support covers.Since there were no parts returned from the field or log files provided, a cause of the issue could not be determined by ct engineering.However, based upon the troubleshooting services and statements of the fse, a probable cause was determined that the issue occurred due to the covers falling down and being out of position.Ct engineering determined this issue to be an acceptable risk and if the malfunction were to recur it would not be likely to cause or contribute to death or serious.The fse repositioned the covers to enable the customer to continue using the equipment with caution until the covers could be replaced.The fse confirmed that all telescoping patient support covers have been replaced and the system is functioning as designed.

Event Description

The customer reported that while in the process of starting a patient procedure, with the patient sitting on the patient support, the patient support fell in the downward vertical direction15 cm.Philips service confirmed there was no harm to a patient, operator or bystander as a result of the reported event.The philips field service engineer instructed the customer to not use the system until it was evaluated.

• Brand Name: BRILLIANCE 16
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 3723880
• MDR Text Key: 4329573
• Report Number: 1525965-2014-00062
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2014

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: 728245
• Device Catalogue Number: NCTA40
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 02/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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