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

Catalog Number 404008

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

Customer reports via phone that during an undetermined urology procedure, the system fluoro failed.Customer would provide no further patient or procedural information, other than to say the patient is fine.No reported injury.

Manufacturer Narrative

Facility biomed called lf service saying he had ordered and received a monitor power supply for the table monitors and was planning to install it himself, but wanted to know where it was located in the table.Mallinckrodt technical service explained where the power supply for the table monitors was located.Field service engineer (fse) followed up with the biomed who said that he was able to find and replace the old power supply with the new one.Customer repair.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: IXR
• 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: 4192540
• MDR Text Key: 5162748
• Report Number: 1518293-2014-00135
• 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 Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/07/2014

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 Catalogue Number: 404008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2006
• 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