MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD

Model Number 404008

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Failure to Power Up (1476); Device Stops Intermittently (1599); Computer Operating System Problem (2898); Failure to Shut Off (2939)

Patient Problem No Information (3190)

Event Date 05/19/2017

Event Type  malfunction  

Event Description

Sedecal integrated console display out.Patient was on the table and the sedecal integrated console went blank.Reboots of the console would not bring up the screen.Patient had to be moved to another room.There was a "foob" for the console.Intermittently generator console (old style) freezes and will not reboot.New console will not power on/off generator.The first replacement console was reported as a failure out of box and returned to lf for evaluation on rga 57221811.Evaluation of this console was done by r and d ((b)(6)) who found that the console would power on but not turn on the generator.Further investigation found cause was a broken c1 capacitor on the `turn on' pcb located at the bottom of the console enclosure.The console was returned to sedecal for repair.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT EXT DR FINAL ASSY-STANDARD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 6646695
• MDR Text Key: 77940665
• Report Number: 1518293-2017-00017
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 404008
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2017
• Date Device Manufactured: 12/31/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1