MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PRECEDENCE; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number PRECEDENCE 16-2169-3001A

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

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: (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 radius 1 motion continued to move after the operator removed her finger from the virtual hand controller (touchscreen).The operator activated the collision sensors on detector 1 and motion stopped.There was no harm.The system was in clinical use.Based on the available information, this issue has been initially determined to be a reportable event.

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 radius 1 motion continued to move after the operator removed her finger from the virtual hand controller (touchscreen).The operator activated the collision sensors on detector 1 and motion stopped.There was no harm.The system was in clinical use.Based on the available information, this issue has been initially determined to be a reportable event.

Manufacturer Narrative

The issue reported was that radius 1 motion continued to move after the operator removed her finger from the virtual touchscreen hand controller.The system was in clinical use when this occurred.The philips field service engineer (fse) went on site to evaluate and confirm the reported issue.The fse reported that the operator was setting up a total body (tb) scan and was moving detector 1 in toward the patient using the virtual hand controller on the touchscreen.When they removed their finger from the touch screen, the radius 1 motion continued to move toward the patient.They initiated the collision cover for detector 1 and the motion stopped.The patient was not harmed.The issue could not be reproduced.A new touch screen monitor was installed and tested with no issues.Philips engineering reviewed all available data which confirmed the reported issue through log file analysis.Users should be vigilant while watching the patient and controlling the machine simultaneously and can activate e-stop in case of any unexpected motion.In this complaint, the operator activated a collision sensor and motion stopped.No harm to the patient.Probable cause: the probable cause was the virtual touchscreen.Internal cross reference: complaint (b)(4).

• Brand Name: PRECEDENCE
• Type of Device: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10555377
• MDR Text Key: 207584660
• Report Number: 3015777306-2020-00014
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K041218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRECEDENCE 16-2169-3001A
• Device Catalogue Number: 882350
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/28/2020
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1