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

Catalog Number III

Device Problems Mechanical Jam (2983); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that after completing a patient procedure, the ct table was lowered utilizing the multifunction footswitch, and when the operator released the footswitch, the ct table continued to move.A philips field service engineer (fse) confirmed there was no harm to a patient, operator, or bystander.The customer reported that the vertical table movement stopped when the operator stepped on the footswitch again.The fse evaluated the ct system and determined that contrast medium had leaked into the multifunction footswitch and the footswitch had become stuck engaged.The fse replaced the failed portion of the multifunction footswitch 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 (b)(6)-2015, the customer, (b)(6), reported that during a patient clinical procedure while attempting to unload the patient from the system using the unload pedal of the footswitch, the patient support continued to move downwards even when the pedal was released by the operator.There was no report of harm to a patient, operator or bystander associated with this issue.The operator was able to successfully remove the patient from the system in a controlled fashion.The operator stated that the patient support uncommanded movement stopped when the footswitch pedal was pressed again.The operator contacted the philips help desk to inform them about the incident and a philips field service engineer (fse) was dispatched.The fse arrived on site and evaluated the system.Upon evaluation, the fse determined that the pedals of the footswitch were stuck engaged by ingress of excessive contrast, causing the uncommanded motion.The fse replaced the pedals of the footswitch, which was full of contrast.The fse did not replace the entire footswitch, only the pedals.However, on (b)(6) 2015, the same issue recurred at the site.This time, the uncommanded motion was also in the downward direction when the unload pedal of the footswitch was pressed to unload a patient from the system following a clinical procedure.There was no report of harm to a patient, operator or bystander associated with this issue, the operator was able to successfully remove the patient from the system in a controlled fashion.The operator contacted the philips help desk to inform them about the incident and the fse was dispatched again.This event is addressed by a subsequent complaint.The fse evaluated the system and determined that the unload pedal was stuck again by ingress of contrast inside the footswitch.This time, he replaced the entire footswitch, which resolved the issue.After this service, there have been no further recurrences at the site.The fse did not provide the failed footswitch or log files for engineering assessment.Since there were no parts returned from the field or log files provided, a root cause of the issue could not be determined by engineering; however, based upon the troubleshooting services and statements of the fse, a probable root cause was determined that the issues occurred due to stuck footswitch because of contrast ingress.After the first event, the fse cleaned the footswitch and replaced only the pedals but after the second event, the fse replaced the footswitch to resolve the issue.Since there were no parts returned from the field or log files provided, a root cause of the issue could not be determined by engineering; however, based upon the troubleshooting services and statements of the fse, a probable root cause was determined that the issues occurred due to stuck footswitch due to contrast ingress.

• 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: 4791763
• MDR Text Key: 21464402
• Report Number: 1525965-2015-00144
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 04/27/2015

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: Health Professional
• Device Catalogue Number: III
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/23/2015
• 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