MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. MX 8000; COMPUTED TOMOGRAPHY X-RAY

Model Number 728130

Device Problem Defective Component (2292)

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

Engineering analysis concluded that this event has the potential to result in image misinterpretation due to an artifact from a degraded compensator within the collimator.Therefore, this issue has been determined to be a reportable event.

Manufacturer Narrative

The customer reported intermittent image artifacts.There was no report of misrepresentation as a result of the artifacts.A philips field service engineer (fse) confirmed there was no harm to a patient as a result of this reported issue.The fse confirmed that artifacts were present on scan images.The fse visually inspected the system and found the a-plane collimator had failed.The a-plane collimator was replaced to resolve the issue, and the system was returned to clinical use.This issue has been determined not to be a reportable event.

• Brand Name: MX 8000
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 7231285
• MDR Text Key: 98785017
• Report Number: 1525965-2018-00148
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K010817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728130
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1