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

Catalog Number III

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

In this case the customer reported that after moving the patient to the desired position utilizing the fast advance button on the gantry control panel, the operator released the button and the table continued to move 24 inches.A philips field service engineer (fse) confirmed that there was no harm to a patient, operator or bystander.The fse evaluated the error logs and could find no error.

Manufacturer Narrative

(b)(4).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 23-mar-2015, a philips field service engineer (fse) reported that there is an intermittent patient support movement issue at the customer site advanced medical imaging center, california.The fse stated that on (b)(6) 2015, when the operator used the gantry panel in button to position the patient to start a clinical scan procedure, the patient support continued to move 2-3 feet towards the gantry, even when the operator released the button.The fse added that the patient's arm collided with the gantry and stretched the arm to a painful position.The operator was able to reposition the patient correctly and complete the scan successfully.The fse confirmed that the patient was not injured but had temporary pain and did not received any medical treatment for the same.There was no additional harm to the patient and there was no harm to an operator or bystander as a result of this issue.This issue was verbally reported by the customer to the fse when he was on site on (b)(4) 2015.Since this issue was intermittent at the site, there was no service call opened for this event; therefore, on (b)(4) 2015, the fse opened this call to report the event that occurred on (b)(6) 2015.The fse could not confirm if the customer was using normal in or the fast in button in the gantry panel.However, when the fse checked the log files, he did not find any errors corresponding to any of the events reported by the customer.The fse could not duplicate the problem; therefore, based on the customer statements and the symptoms the fse proactively replaced the multifunction footswitch and the right gantry control panel.The replaced footswitch and gantry panel were not provided for investigation.The fse provided the log files for engineering evaluation.Bugreps for specific occurrences were not provided by the customer for further evaluation by ct engineering.Engineering reviewed the log files and stated that from all the log files provided, this occurrence was not noted.There are no can trace logs available for this reported event.Also, no evidence of uncommanded motion was found in the log files, as stated by the fse earlier.Therefore, with the limited information, the cause of the 2-3 feet excessive motion of the couch could be one of two scenarios: 1.The user was not utilizing the fast in button correctly.The user was using this button for slow horizontal motion, but since this button is designed for faster motion, the couch moved to a greater distance after the button was released.2.An issue that was fixed in the later version of software (v4.1.4).In these cases, the user presses the fast horizontal in button on the gantry panel, and then releases it after about 100 msec and then represses in 200 msec.Due to this, the couch software begins to start a move then cancels the move but is immediately told to restart the move again, causing motion issues with the couch.A review of the service work orders (swo) at the site showed that the software upgrade to v4.1.4 was implemented at the site on (b)(4) 2015.After the software upgrade, there have been no recurrences of the motion issues at the site.Since no evidence of motion could be found on the log files and after the software upgrade to v4.1.4, the issue did not recur again, a probable cause for these intermittent events could be that the user was not utilizing the fast horizontal in button correctly.Ct engineering stated that since no evidence of motion could be found on the log files and after the software upgrade to v4.1.4, the issue did not recur again, a probable cause for these intermittent events could be that the user was not utilizing the fast horizontal in button correctly.This issue is considered no hazard as the un-commanded motion of 2-3 feet was not seen in the logs.Moreover, instruction for use for ingenuity ct (page 101) warns the user " watch the patient at all times during all table movements (vertical and horizontal) to ensure safety of the patient and avoid collision between the patient and gantry." subsequent complaints were entered for the intermittent events and determined to be similar occurrences of the issue.The fse proactively replaced the footswitch and the right gantry panel.Also, the system software was upgraded to v4.1.4 on 19-jun-2015.

• Brand Name: INGENUITY CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• 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: 4812152
• MDR Text Key: 5836299
• Report Number: 1525965-2015-00151
• 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: 05/06/2015

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 Catalogue Number: III
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 06/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2015
• 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