HUT EXT DR FINAL ASSY-REVERSE 404007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim.

Event Text Entries

[106897974] Fluoro issues - will not fluoro. Indicated received an aec error on the sedecal console. The customer could not indicate if an error code was associated. Cleared the alarm, cycled power on the sedecal and the infimed platinum one. After the power cycle the system would fluoro then it would not. Unable to determine the exact cause at this time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1518293-2018-00012
• MDR Report Key: 7463906
• Date Received: 2018-04-26
• Date of Report: 2018-04-26
• Date of Event: 2018-03-29
• Date Mfgr Received: 2018-03-29
• Device Manufacturer Date: 2005-02-28
• Date Added to Maude: 2018-04-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RADIOLOGIC TECHNOLOGIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: FRED RECKELHOFF
• Manufacturer Street: 2111 E. GALBRAITH RD
• Manufacturer City: OH 45237
• Manufacturer Country: US
• Manufacturer Postal: 45237
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Generic Name: HUT EXT DR FINAL ASSY-REVERSE
• Product Code: IXR
• Date Received: 2018-04-26
• Model Number: 404007
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LIEBEL-FLARSHEIM
• Manufacturer Address: 2111 E. GALBRAITH RD CINCINNATI OH 45237 US 45237

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-04-26