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

Model Number HUT EXT DR FINAL ASSY-REVERSE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

Biomed called service reporting that operator heard a popping noise and they now have an error 53 on the generator.Tech service explained that an error 53 is a drac error indicating that was not enough voltage on the bus.Biomed asked for some quick checks he could do before asking for fse to come in, service told biomed it appeared to be a drac failure.Biomed ordered drac and installed it.On system power up, the computer (infimed platinum one) would not boot up and sedecal x- ray console screen locked up.Fse went on site, troubleshot and replaced the computer power supply and the computer functions normally.Fse then troubleshot and isolated the console problem to the atp console pcb.However, the customer declined repair due to cost of part and the system being removed (b)(6) 2015.The table could still be used for non-imaging cases, and it was returned to the customer for limited service.

Event Description

Customer reports the system fluoro failed during an unknown procedure.Staff moved the patient to another room to complete the procedure.No reported injury.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: HUT EXT DR FINAL ASSY-REVERSE
• 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: 5123547
• MDR Text Key: 27641381
• Report Number: 1518293-2015-00095
• 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
• Report Date: 09/10/2015

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-REVERSE
• Device Catalogue Number: 404007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2004
• 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