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

Model Number 404007

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2015

Event Type  malfunction  

Event Description

Customer reports via phone that during an undetermined urology procedure, the system monitors failed and the staff had to move the patient to another room, where procedure was completed without further incident.Customer provided no patient or procedure information, other than to say the patient is fine.No reported injury.

Manufacturer Narrative

Field service engineer (fse) troubleshot system whose computer intermittently locked up and found the pc hard drive was causing the problem.Fse replaced the hard drive, reconfigured and the unit operated normally.Unit was then checked for proper operation per service checklist and returned to full service.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• 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: 4782190
• MDR Text Key: 5802876
• Report Number: 1518293-2015-00049
• 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: 05/07/2015

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: 404007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 05/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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