MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH EASYDIAGNOST ELEVA; TABLE, RADIOGRAPHIC, TILTING

Model Number 448485

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

Received "handle error, call service" message on philips fluoroscopy room 2 during pediatric ugi/ esophageal exam.Table bucky, upright bucky, and fluoroscopy not working.

• Brand Name: EASYDIAGNOST ELEVA
• Type of Device: TABLE, RADIOGRAPHIC, TILTING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; 100 park avenue; suite 300; orange village OH 44122
• MDR Report Key: 12540457
• MDR Text Key: 273650851
• Report Number: 12540457
• Device Sequence Number: 1
• Product Code: IXR
• 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: 09/14/2021,09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 448485
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1