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

Model Number HUT EXT DR FINAL ASSY-STANDARD

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

Biomed reported a problem with the console he had just installed himself, that during a procedure it would take a couple pictures (images) and then need to be restarted.Field service engineer (fse) went on site and found a problem with the biomed's setup on the console.When a console is replaced it has to be configured correctly.The configuration in the console can be set for a hut plus system with filmer, a hut es system or a hut dr.In this case the biomed did not select hut dr when he replaced the console and this caused the reported problem.Fse corrected the setup, calibrated the touchscreen and verified proper operation per manuals (b)(4).There was no defect of malfunction of equipment.The installation instruction for the generator console (p6 of instructions (b)(4) 2012) alert the installer to this issue.

Event Description

Customer reports that during an unknown patient procedure the system fluoro failed.They rebooted the system and were able to take a couple of fluoro runs, then it failed again.They moved the patient to another room and completed the case 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: 5246058
• MDR Text Key: 32220772
• Report Number: 1518293-2015-00119
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/16/2015

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2008
• 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