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

Model Number 404008

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

Customer reports via phone that during a retrograde cystogram on a female patient, under general anesthesia, the system fluoro failed.Staff moved the patient to another room where the procedure was completed without further incident.Customer did not provide the patient age, and reports the patient is fine.No reported injury.

Manufacturer Narrative

Tech service spoke with the facility biomed who said that the sedecal touchscreen was coming up with the message "system event logs full" at power up.Tech service advised biomed on how to clear the log files in windows to get rid of this message.There were no other reported issues at this site.This issue did not prevent the x-ray generator from being used.A review of cts showed no similar issue reported on this unit in cts.Unit returned to full service.Biomed advised on phone by tech support.

• 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: 4726507
• MDR Text Key: 15897619
• Report Number: 1518293-2015-00029
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2015

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: 404008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2010
• 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