MAUDE Adverse Event Report: ;OEBE; F;ARSJEO, HUT EXT DR FINAL ASSY-STANDARD

Model Number HUT EXT DR FINAL A

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

Customer reports via phone that during an undetermined urology procedure, the fluoro footswitch failed, and no fluoro image could be obtained.Physician completed the procedure by using rad imaging shots.Customer would not provide any further patient or procedural information other than to say the patient is fine.No reported injury.

Manufacturer Narrative

Tech service discussed with biomed intermittent issues he had.Biomed mentioned that he had repaired a bad x-ray footswitch and the fluoro image would intermittently fluctuate up and down.Tech service explanted that this could be caused by a number of items in the fluoro chain from the sedecal to the tube and back to the image intensifier (ii).On (b)(4), a field service engineer (fse) went on site and found the fluoro image was going and out of focus, the table display was blank, and the table motions were erratic.Fse troubleshot these issues and resolved them by replacing the 24v power supply to the table.Fse checked the system for proper operation per service checklist qssrwi4.1 and returned the unit to the customer for service.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Manufacturer (Section D): OEBE; F;ARSJEO,; 2111 east galbraith rd.; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith rd.; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 4095501
• MDR Text Key: 21316903
• Report Number: 1518293-2014-00105
• 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: 08/19/2014

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?: Yes
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2005
• 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