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

Model Number 728332

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 pr# (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 that an error message appeared during a biopsy procedure.This issue is currently under investigation.This malfunction may be likely to cause or contribute to a death or serious injury if this were to recur.Based on the available information, this issue has been initially determined to be a reportable event.

Manufacturer Narrative

The customer reported during a biopsy procedure, there was a tape switch error message when the doctor was advancing the table into the ct gantry bore.A new series was planned to clear the error message and the biopsy was completed.A patient was on the table during the lung biopsy.The patient was out of the bore as the doctor was positioning the needle.When the doctor attempted to move the patient back into the bore of the ct system using the joystick option, they received a message on the monitor to release the tape switch.The customer alleged no one was touching the tape switch or foot switch at the time.A new series was planned and they proceeded with the biopsy.The philips field service engineer (fse) was requested on site to inspect the system.The fse reviewed log files which confirmed a tape switch error message occurred during the procedure.The fse explained this type of message will occur during couch positioning if two actions are performed simultaneously (i.E.The doctor advances the table with the joy stick and a technologist, at the same time, attempts to advance the table with the foot switch, gantry button, or tape switch).The fse inspected the system and found no malfunctions of the system.The probable cause of this issue is that the doctor advanced the table with the joy stick and a technologist, at the same time, attempted to advance the table with the foot switch, gantry button, or tape switch.Based on further investigation, it has been determined there was no malfunction of the ct system and this issue is no longer a reportable event.A tape switch error was confirmed in the log files.Tape switch errors are a result of two actions being performed by the user at the same time to advance the ct table.The patient developed a pneumothorax after the lung biopsy procedure.The philips physician confirmed a pneumothorax is a known short-term complication when a lung biopsy is performed during a trans-bronchial or trans-thoracic needle biopsy.The tape switch error did not cause the patient's pneumothorax.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: IQON SPECTRAL CT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 9005868
• MDR Text Key: 181759436
• Report Number: 1525965-2019-00059
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K133674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 728332
• Device Catalogue Number: 728332
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 99