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

Model Number HUT EXT DR FINAL ASSY-REVERSE

Device Problems High Readings (2459); Device Operates Differently Than Expected (2913)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

Biomed called service and stated that a physicist was just there to check the system and the physicist said the system was reading a fluoro max dose of about 13r/min and he needs to adjust it down to just below 10r/min.Tech service explained to biomed how to adjust the max dose.Biomed was to call back if needed.Tech service reports that the hospital's biomed(s) take care of this system and they only call for a field service engineer (fse) on major service calls.The last time an fse was at this site was on (b)(6) 2015 service ticket: (b)(4).The last time one of liebel flarsheim's (lf) field engineers would have checked the dose was on service ticket: (b)(4), (b)(6) 2013 when service upgraded the x-ray generator and replaced the x-ray tube.At liebel flarsheim's (lf) request, service spoke with the biomed who reported the initial value for e17 = 140 with the dose at 13r/min.He dropped e17 = 132 for a dose of 9.4 r/min.

Event Description

During system testing, the physicist stated the system is reading a fluoro max dose of about 13r/min.

• 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: 5437243
• MDR Text Key: 38808737
• Report Number: 1518293-2016-00007
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/20/2016

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 ASSY-REVERSE
• Device Catalogue Number: 404007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2007
• 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