MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 64; COMPUTED TOMOGRAPHY X-RAY

Model Number 728231

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Type  Injury  

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.

Event Description

This complaint has been evaluated based on the information provided.The issue reported was that a philips field service engineer (fse) injured his right hand in the upper part of the couch while completing a preventive maintenance (pm).The fse broke the second finger of his right hand and his right palm was injured.The fse received surgery the same day.Based on the available information, this issue has been determined to be a reportable event.

Manufacturer Narrative

A philips field service engineer (fse) was on site for preventive maintenance (pm).The ct technologist asked the fse to inspect the ct couch because it was making a noise during vertical movement.The fse proceeded to inspect the couch motor without first installing the safety bar and injured his right hand when removing the couch vertical motor.The fse was treated for a broken finger and damage to a large area of skin on his hand.The following has been confirmed: the fse was trained to all fse training to work in the field; all system warning labels stating to install the safety bar were in english and intact; the fse speaks and reads english and understands the system warning labels; the fse has experience with ct couch maintenance and has successfully used the safety bar during previous service events; the safety bar was not secured during this service event.The probable cause of the reported issue is due to the fse forgetting to install the safety bar which prevents injury during couch maintenance.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: BRILLIANCE 64
• Type of Device: COMPUTED TOMOGRAPHY X-RAY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 9106577
• MDR Text Key: 163386023
• Report Number: 1525965-2019-00060
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K033326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 728231
• Device Catalogue Number: NCTB423
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR