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

Model Number HUT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2015

Event Type  malfunction  

Event Description

Customer reports via phone that during an ercp procedure, the system fluoro failed.Staff moved the patient to another room, where the procedure was completed without incident.Customer did not provide any further patient of procedural information, other than to say the patient is fine.No reported injury.

Manufacturer Narrative

Customer initially called service reporting a site key issue.A field service engineer (fse) went on site, logged into the system as an administrator and re-entered the site key registration number.System operated normally when tested per service checklist (b)(4) and was returned to customer for use.When we called customer for additional info, we were told when starting an ercp procedure, the system fluoro failed.Staff moved the patient to another room, where the procedure was completed without incident.Quality assurance checked with tech support regarding the two reported issues and was told that even though these seem like different issues, if the system doesn't have the site key it won't work; thus, fluoro would not work.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT
• 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: 4524948
• MDR Text Key: 5492484
• Report Number: 1518293-2015-00007
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/02/2015

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: HUT
• Device Catalogue Number: 404008
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2007
• 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