MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 6 AIR; COMPUTED TOMOGRAPHY X-RAY

Model Number 728256

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

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 (b)(4).

Event Description

A philips field service engineer reported that while at the site, he observed about 10 cm of the glue securing the gantry front cover to the metal bar is broken/lifted.The cover is still secured to the metal bar and no injury has occurred.Philips design engineering and systems engineering determined that the separation of the glue securing the gantry front cover could potentially continue until full separation occurs, allowing the front cover to fall, which could result in patient injury.

Manufacturer Narrative

A philips field service engineer (fse) reported that while at the site, he observed about 10 cm of the glue securing the gantry front cover to the metal bar is broken/lifted.There was no patient impact.Philips design engineering and systems engineering reviewed the pictures that were taken at the site.It was determined that the system should be taken out of service until the cover could be replaced.Philips service has since replaced the gantry front cover to resolve the issue.The system is operational and in clinical use.

• Brand Name: BRILLIANCE 6 AIR
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: derrick massuri ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 6936838
• MDR Text Key: 89811708
• Report Number: 1525965-2017-00019
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728256
• Device Catalogue Number: NCTA396
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• 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