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

Model Number HUT EXT DR FINAL A

Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

Customer reports via phone that during an undetermined urology procedure, the staff reported the computer would not allow them to enter patient information, and fluro failed.Staff moved a portable c-arm fluoro unit into the room, and the procedure was completed without further incident.Customer provided no further patient or procedural information, other than to say the patient is fine.No reported injury.

Manufacturer Narrative

The field service engineer (fse) investigated the custome's report that they were unable to get fluoro and that a message on the generator console stated that the park arm was retracted when it was not.Fse verified park arm movement and limits, and re-adjusted the decel (de-acceleration) from 90 to 75 which is the manufacturer recommended setting.Fse reported that he was unable to duplicate the park arm message on generator console unless the park arm was retracted a little (i.E.Not in correct position).Fse also reported that the fluoro was working properly.Customer had also said that they had received a pop up message on the infimed imaging monitor about deleting info and that they were unable to enter patient info.Fse was not able to duplicate this message described by customer.System was working normally.Fse verified system opertion acording to service checklist qssrwi4.1, and returned the unit to the customer for full service.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• 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: 4095500
• MDR Text Key: 4832393
• Report Number: 1518293-2014-00101
• 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: 08/12/2014

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: 404007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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