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

Model Number	BRILLIANCE 64 UPGRADES
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not completed our investigation of this event.We will file a followup emdr at the completion of the investigation.(b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided.The issue reported was that the customer finger was pinched and broken while operating the couch horizontally.Based on the available information, this issue has been determined to be a reportable event.Therefore, this complaint is considered to be a reportable event to the regulatory agency per (b)(4) adverse event reporting procedure (ct/nm).This issue is not a reportable radiation event per (b)(4) ct/ami radiation event reporting.
Additional Manufacturer Narrative
The customer reported that the user¿s left thumb was pinched while operating the couch horizontally and as a result could not bend their left thumb.An xray examination was performed which confirmed that the left thumb was broken.No additional medical intervention was received by the user.The philips field service engineer (fse) performed an interview investigation.The fse found that there was no problem with the operation of the equipment.There were no parts replaced.This issue was due to use error.Therefore, there was no malfunction of the device.Internal cross reference number: (b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided.The issue reported was that the customer finger was pinched and broken while operating the couch horizontally.Based on the available information, this issue has been determined to be a reportable event.Therefore, this complaint is considered to be a reportable event to the regulatory agency per (b)(4) adverse event reporting procedure (ct/nm).This issue is not a reportable radiation event per (b)(4) ct/ami radiation event reporting.

• Brand Name: BRILLIANCE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner road; cleveland OH 44143
• MDR Report Key: 9811480
• Report Number: 3003768277-2020-01002
• Device Sequence Number: 13647816
• Product Code: JAK
• UDI-Device Identifier: 00884838083325
• UDI-Public: 00884838083325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BRILLIANCE 64 UPGRADES
• Device Catalogue Number: 728231
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/29/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Weight: 43