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

Catalog Number III

Device Problems Mechanical Jam (2983); Positioning Problem (3009); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2015, the customer reported that after completing a patient procedure, while trying to unload the patient from the system using the unload pedal of the footswitch, there was uncommanded motion of the patient support in the downward direction.The patient support continued to move downwards, even though the operator had released the pedal.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 about the incident and the fse was dispatched again.The same issue had occurred at the site prior to this event, on (b)(6) 2015.This event is addressed by a previous complaint.The fse evaluated the system and determined that the unload pedal was stuck by ingress of contrast inside the footswitch.The fse replaced the entire footswitch which resolved the issue.After this service, there have been no further recurrences at the site.Since there were no part 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.

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.

• 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: 4944015
• MDR Text Key: 23009393
• Report Number: 1525965-2015-00210
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Report Date: 05/19/2015

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: Not provided
• Initial Date FDA Received: 07/27/2015
• 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