MAUDE Adverse Event Report: PHILIPS BRILLIANCE CT SCANNER; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Break (1069)

Patient Problem Abrasion (1689)

Event Date 05/11/2020

Event Type  malfunction  

Event Description

Mylar casing was chipped upon entry to ct scanner.Patient's arm rubbed across the mylar casing causing abrasion to left hand.

• Brand Name: BRILLIANCE CT SCANNER
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS; 4430 rosewood drive; suite 200; pleasanton CA 94588
• MDR Report Key: 10100869
• MDR Text Key: 192670638
• Report Number: 10100869
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA