MAUDE Adverse Event Report: GE GE ADVANTX LEGACY D RAD/FOURO; ROOM SN785452SR3

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 09/24/2018

Event Type  malfunction  

Event Description

The patient was placed on her right side under the fluoro tower.The tower was not properly locking and when it moved the tower locked into place and it also came down on the patient.Resting on the patient's hip and incision causing pain.

• Brand Name: GE ADVANTX LEGACY D RAD/FOURO
• Type of Device: ROOM SN785452SR3
• Manufacturer (Section D): GE
• MDR Report Key: 8419989
• MDR Text Key: 138818660
• Report Number: 8419989
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/02/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2019
• Distributor Facility Aware Date: 09/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 101