MAUDE Adverse Event Report: LIEBEL-FLARSHEIM MALLINCKRODT LIEBEL-FLARSHEIM MALLINCKRODT HYDRA VISION PLUS DR; HYDRA VISION PLUS DR VERTICAL DIAGNOSTIC BUCK

Model Number HYDRA VISION PLUS D

Device Problem Smoking (1585)

Patient Problem No Information (3190)

Event Date 01/09/2019

Event Type  Injury  

Event Description

During use, whitish acrid smelling smoke was noted to be rising from top of cabinet.There were no flames seen.Power supply to the device was disconnected and the smoke and smell began to dissipate.

• Brand Name: LIEBEL-FLARSHEIM MALLINCKRODT HYDRA VISION PLUS DR
• Type of Device: HYDRA VISION PLUS DR VERTICAL DIAGNOSTIC BUCK
• Manufacturer (Section D): LIEBEL-FLARSHEIM MALLINCKRODT
• MDR Report Key: 8266385
• MDR Text Key: 133713917
• Report Number: 8266385
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HYDRA VISION PLUS D
• 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: 01/11/2019
• Distributor Facility Aware Date: 01/01/2019
• Device Age: 15 YR
• Event Location: Hospital
• 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
• Treatment: RADFLUROSCOPIC TABLE, UROLOGIC
• Patient Outcome(s): Other; Required Intervention