MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. MX 4000; COMPUTED TOMOGRAPHY X-RAY

Model Number 728126

Device Problems Signal Artifact/Noise (1036); Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

The customer reported that images acquired during a pt procedure exhibited artifacts.At this time, there is limited info available as to the type of artifact.There is no report of harm to a pt, operator, or bystander.

Manufacturer Narrative

(b)(4).We will file a follow up mdr at the completion of the investigation.(b)(4).

Manufacturer Narrative

Follow-up #2 correction emdr is being sent to address that an initial mdr and follow-up #1 emdr as submitted in error as this product is not sold or distributed in the united states.Also, there is no install base of this product in the united states.

Manufacturer Narrative

(b)(4).On (b)(6) 2014, the customers at (b)(6) contacted the philips help desk and reported artifacts on the images from their mx 4000 system.There have been no reports of any misinterpretation or rescan; there has been no harm to a patient, operator or bystander due to this issue.The quality assurance analyst was contacted to obtain more information.The qa analyst contacted the customer, who did not provide any information about the type of artifact exhibited on the system.They also stated that no philips field service engineer (fse) was dispatched to the site and that they resolved the issue themselves.The customer also stated that there is no further recurrences of the artifacts at the site.However, the customer did not provide information about the fix for the issue and said that they would like to cancel the case entered in this complaint.Several attempts were made to the customer to obtain more information about the artifacts and the resolution, but no response was obtained from the customer.Since no information could be obtained from the site about the type of artifacts and the correction performed at the site by the customer to resolve the issue, a risk assessment or root cause could not be made.The customer stated that there is no further recurrences of the artifacts and that they would like to cancel this case.

• Brand Name: MX 4000
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd.; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 4373622
• MDR Text Key: 5233778
• Report Number: 1525965-2014-00212
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728126
• Device Catalogue Number: NCTC170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1