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

Model Number HUT EXT DR FINAL ASSY-STANDARD

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

Tech service troubleshot with biomed who reported generator errors 11 and 53, both of which indicated that there was no dc buss voltage.Biomed also said he saw an alarm 15 at one point which would indicate no filament drive to the x-ray tube or that the filament was burned out.Biomed also said that the computer showed a gim communication error.Tech service explained to biomed that he would first need to get the generator past the error 11 and 53 and gave biomed steps take to check the system and to determine the cause of the problem.Biomed called back after checking system per tech service advise, and stated that he power cycled the computer and gim and this had resolved the gim communication error message.Then he had found a blown 3f6 fuse on the generator and after replacing the fuse, the generator came back up without error.Biomed reported that the system was now fully functional and was taking fluoro / rad exposures as normal.

Event Description

Customer reports the system failed with errors that show no dc buss voltage during an unknown procedure.Staff moved the patient to another room and completed the procedure without incident.No reported injury.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT EXT DR FINAL ASSY-STANDARD
• Manufacturer (Section D): LIEBEL FLARSHEIM; 2111 east galbraith road; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith road; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 5448328
• MDR Text Key: 39127281
• Report Number: 1518293-2016-00014
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/15/2016

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: Health Professional
• Device Model Number: HUT EXT DR FINAL ASSY-STANDARD
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1