MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. IQON SPECTRAL CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number IQON SPECTRAL CT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was the bed unintentionally lowered during a patient procedure and pulled out the patient's intravenous (iv) drip.This caused the iv site to bleed.Based on the information provided, this event does not meet the criteria for a serious injury.It was indicated that there was no patient effect due to this event.Bleeding from an iv site is common and/or minimal when an iv is removed from the access site, and may be treated with applied pressure and a band-aid.Based on the available information, it is unknown if the reported event would be likely to cause or contribute to a death or serious injury if it were to recur.Therefore, this event is being reported conservatively.

Manufacturer Narrative

The issue reported was during a patient study, the couch allegedly moved unintentionally and resulted in an intravenous infusion (iv) to detach from a patient.There was no serious injury reported and the iv was restarted with no issues.The procedure was then completed.A philips field service engineer (fse) confirmed the customers allegations there were 3 instances of unintentional movement while positioning a patient on the table: first instance: the table went down to its lower limit allegedly without the operator touching the gantry panel.The user moved the table back up vertically using the footswitch.Second instance: the bed allegedly moved out and down vertically to the lower limit again.Once again, the user moved the table back up again vertically using the footswitch.Third instance: the bed allegedly moved out and down vertically to the lower limit again.The customer states the buttons on the right touch panel appeared active even though the user was not touching the gantry panel.The customer cleaned the gantry panel and rebooted the system and completed the patient study with no further issues.The fse evaluated the system and found not issue with the right-side liquid crystal display (lcd) assembly touch panel.He also attempted to replicate the issue however was not successful.He proactively replaced the right-side liquid crystal display (lcd) assembly touch panel and returned the system to the customer for clinical use.Logfiles for the event were obtained and sent to philips engineering for analysis.Philips engineering reviewed all details and logfiles for the event and concluded: the couch¿s unintentional movement was caused by an unintended table movement command sent by the gantry touch panel.The probable cause of this gantry touch panel malfunction is: 1) potential contamination/taint of the gantry touch panel by some fluids like contrast media, saline, etc.2) miss calibration or lack of calibration for the gantry touch panel after cleansing the touch panel when panel malfunction happened by contamination/taint per the instructions for use manual: the system is equipped with emergency stop buttons that will halt all system motion when activated.During all movements of the gantry and the patient table (automatic and manual), keep the patient under continuous observation.Take care to avoid pressing the patient against the gantry or between table parts, as well as to avoid disconnecting any infusion or resuscitation apparatus.The fse proactively replaced the right-side lcd assembly touch panel.Therefore, based on the investigation performed, this event is considered a non-reportable event.The system did not cause or contribute to a death or serious injury, or serious deterioration and would not cause a death or serious injury, or serious deterioration if this event were to recur.Internal cross reference: complaint (b)(4).

• Brand Name: IQON SPECTRAL CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: beth johnson ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16758705
• MDR Text Key: 313511634
• Report Number: 3015777306-2023-00004
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00884838059542
• UDI-Public: 00884838059542
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IQON SPECTRAL CT
• Device Catalogue Number: 728332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Date Device Manufactured: 02/21/2019
• 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