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

Model Number HUT EXT DR FINAL A

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

Customer reports via phone that during an undetermined urology procedure, the system overheated and fluoro failed.Staff moved the patient to another room where the procedure was completed without further incident.No reported injury.Customer did not provide any further patient or procedure information, other than to report the patient is fine.

Manufacturer Narrative

Field service engineer (fse) troubleshot system and found that the digital spot settings in the adult mode were at 40 kv, 160 ma, at 2 sec backup time.Fse reset to the default settings of 75 kv, 250 ma, 2 sec backup time; tested the system's heat unit output and found the system functioning normally.This was operator error.Fse inserviced customer on how to reset settings to default.Fse was unable to determine how settings got changed.Fse completed the hydravision dr system service checklist (b)(4) and returned unit to the customer for full service.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Manufacturer (Section D): LIEBEL FLARSHEIM; 2111 east galbraith rd.; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith rd.; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 4095511
• MDR Text Key: 4834497
• Report Number: 1518293-2014-00108
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2014

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 Model Number: HUT EXT DR FINAL A
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• 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