MAUDE Adverse Event Report: PHILIPS EASYDIAGNOST ELEVA; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE - INTENSIFIED

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2019

Event Type  malfunction  

Event Description

Fluoroscopy unit stopped working during procedure.Fda safety report id# (b)(4).

• Brand Name: EASYDIAGNOST ELEVA
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE - INTENSIFIED
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 8574013
• MDR Text Key: 144105279
• Report Number: MW5086346
• Device Sequence Number: 0
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR