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

Model Number 404008

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

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

Event Date 09/27/2016

Event Type  malfunction  

Event Description

Bed is working intermittently generator shuts down in the middle of cases.Rad customer is stating they have to reboot the generator multiple times in order to gain function of the fluoro, the customer stated the table will stop functioning intermittently.

• 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 road; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith road; cincinnati, OH 45237
• MDR Report Key: 6053321
• MDR Text Key: 58663523
• Report Number: 1518293-2016-00085
• 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: 10/24/2016

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: Radiologic Technologist
• Device Model Number: 404008
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/25/2016
• Date Device Manufactured: 09/30/2009
• Type of Device Usage: N
• Patient Sequence Number: 1