MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENUITY TF PET/MR; TOMOGRAPHIC IMAGER COMBINING EMISSION CT WITH NULEAR MR

Model Number INGENUITY PET/MR

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020, (b)(6).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 pet/mr table did not stop at the requested position.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 pet/mr table did not stop at the requested position.The system was in clinical use when this event occurred.There was no report of harm.Based on the provided information, this issue has been determined not to be a reportable event.

Manufacturer Narrative

The issue reported was that pet/mr table did not stop at the requested position.The system was in clinical use when this event occurred.There was no report of harm.The philips field service engineer (fse) went on site to evaluate and confirm the reported issue.Per the fse, the customer uses a light-visor to position the patient in the bore of the mr scanner.The customer does this positioning by using a tumble switch to move the patient inside the bore.Normal operation is the table stops at the point the light-visor is set.However, in this event, the table moved over this point.The fse confirmed that when the customer released the tumble switch the table automatically stopped.The fse reviewed logfiles and determined the horizontal encoder had failed.The failed part was replaced, and the table was calibrated to resolve the issue.The system was returned to the customer for clinical use.Probable cause : faulty horizontal encoder.This event is not reportable.Internal cross reference: complaint (b)(4).

• Brand Name: INGENUITY TF PET/MR
• Type of Device: TOMOGRAPHIC IMAGER COMBINING EMISSION CT WITH NULEAR MR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 10700380
• MDR Text Key: 214783748
• Report Number: 3015777306-2020-00017
• Device Sequence Number: 1
• Product Code: OUO
• Combination Product (y/n): N
• PMA/PMN Number: K103483
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INGENUITY PET/MR
• Device Catalogue Number: 882380
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/05/2020
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1