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

Model Number HUT EXT DR FINAL ASSY-REVERSE

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

Pending investigation.Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.

Event Description

Customer reports during a patient procedure the system was locked with the fluoro on (due to a problem with the footswitch sticking internally).Staff hit the emergency stop and completed the case without fluoro.No reported injury and no other details are known.They were not able to get communication with the generator.Biomed found the circuit breaker had been tripped when the emergency stop was pushed.

Manufacturer Narrative

Biomed reported that the system was locked with the fluoro on which he thought was due to the footswitch sticking internally.Staff turned off the system using emergency stop.Next time used, the user couldn't get communication with generator.Biomed checked and found the circuit breaker had been tripped when the emergency stop was pushed, and reported he was able to unstick the footswitch and reset the breaker, so the system was functional at this time.The customer cancelled the service call, but did request a preventative maintenance (pm) to check the system.The pm was done with no issue found by fse and the unit was returned to the customer for full service.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: HUT EXT DR FINAL ASSY-REVERSE
• 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: 5398596
• MDR Text Key: 37231252
• Report Number: 1518293-2015-00125
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• 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 ASSY-REVERSE
• Device Catalogue Number: 404007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2005
• 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