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

Model Number 404008

Device Problems No Display/Image (1183); Loss of Power (1475); Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Event Description

Table is shutting off during cases.Customer states generator screen in the console would go offline as if it lost power, could go over to on/off switch and turn on and it would turn right back on.The 2 monitors on the table were also going black, and could not fluoro.Only way to get back on was to reboot the generator.But today, it was working fine.Main issue - the console/generator is spontaneously shut down, no errors in the log.Nothing per ge fse.Fse reseated several connectors, power relay, etc, and it still shut off.Procedure was not completed and patient was moved to ct and finished.No injuries to patient or staff reported.

• 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
• MDR Report Key: 7549347
• MDR Text Key: 109757314
• Report Number: 1518293-2018-00016
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 404008
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Date Device Manufactured: 05/31/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1