MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 40; COMPUTED TOMOGRAPHY X-RAY

Model Number 728235

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that during a ct clinical patient procedure, the patient support reached the inner most limit and the patient support top was free floating.The philips field service engineer (fse) confirmed that there was no harm to the patient, operator, or bystander.The fse stated that the patient procedure did complete successfully.The fse determined that the service latch was not engaged and had become loose.The fse re-secured the service latch to resolve the issue.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).On 4-may-2015, the customer contacted philips help desk to inform them of an error message they were receiving upon initiating a patient study: "inner-most position¿.Philips service determined that the cause of the error was that the patient support top was free floating.Philips service confirmed that there was no harm to the patient, operator, or bystander.The fse stated that the patient procedure did complete successfully.The fse determined that the service latch was not engaged and had become loose.The fse re-secured the service latch to resolve the issue.If this malfunction were to recur and the subframe service latch were to become disengaged after servicing, prior to a patient procedure, or during a patient procedure, it would be not be likely to cause or contribute to death or serious injury.Based on the risk benefit analysis, trending of the complaint records and a clinical evaluation by a medical physician, it has been determined that service latch failures do not meet the definition of a medical device report.There is no evidence that the service latch failure has resulted in a serious injury or death or could cause or contribute to a serious injury or death if the malfunction were to recur.Service personnel are trained to engage the service latch properly during any service activities that require opening of the gantry front cover.Floating table can be detected by trained personnel during loading/unloading a patient for scanning or loading a phantom for qa checks.Execution of qa checks per user instructions enables detection of table position errors when loading or unloading phantom.Service personnel are instructed to perform auto iq tests (acceptance/constancy and/or quick iq tests) after installation, preventive maintenance (pm), and corrective actions.Execution of auto iq tests, per service instructions, enables detection of table position errors.For oncology usage, positional accuracy testing using the therapy top calibration phantom enables detection of table position errors.During a helical scan, per design, cirs shall verify the couch is moving in the direction specified by the host and shall stop the acquisition if the couch positions are not updated as expected.Operators/users of the system are specifically trained to position a patient in such a way that there is enough play in all indwelling lines and catheters to allow for the table motion that is expected during the scan.There has been no report of injury to a patient, operator or bystander as a result of the service latch becoming disengaged.This customer, advanced diagnostic imaging center, has been confirmed to be on the consignee list for field safety notification (fsn 72800614) that was sent to the field on 08-apr-2014 stating that: if the customer experiences a horizontal, free-floating couch motion, they have to contact their field service engineer immediately.A copy of this field safety notice has to be retained with the equipment instructions for use (ifu).Additionally, the service manual is being revised to provide more robust instructions on how to service the patient support.The service manual changes are internal philips documents.The cause of the disengagement of the service latch could not be determined based on the information provided.

• Brand Name: BRILLIANCE 40
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: nancy drake ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 4812159
• MDR Text Key: 5893777
• Report Number: 1525965-2015-00152
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

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: Other
• Device Model Number: 728235
• Device Catalogue Number: NCTA402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2015
• 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