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

Model Number HUT EXT DR FINAL ASSY-STANDARD

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A physicist found the system is shooting 180% higher than selected kv.Note: this is not the dose of the system.Fse reports:the physicist report showed the fluoro dose measured was 16.5 r/min.I checked the fluoro maximum dose with unfors meter ((b)(4)) and noted the maximum dose was 17.8 r/min.

Manufacturer Narrative

Customer reported that the physicist failed the patient dose display during the inspection, reporting that it was not displaying within the 35% accuracy required under the 1020cfr.Field service engineer (fse) went on site and reviewed the physicist report which showed the fluoro dose measured was 16.5 r/min.Fse checked the fluoro maximum dose with unfors meter (b)(4) and noted the maximum dose was 17.8 r/min.Fse adjusted the adult fluoro maximum dose of 9.44 r/min.Then checked the child dose which was 6 r/min.And adjusted this to yield a child maximum fluoro dose of 4.59 r/min.Fse completed the patient dose display calibration and tested the system using checklist qssrwi4.1 and returned the unit to the customer for service.It was determined to have fse re-measure the dosages on an additional service visit, (b)(4), where fse measured dose for adult at 9.5 r/min., and child at 4.6 r/min.To make sure there was no changes in dosage, fse was scheduled to returned to facility on service (b)(4), where the fse again measured dosage and reported adult = 9.5 r/min child = 4.6 r/min.These dose values reported on these two additional checks, were essentially the same as set by fse on the initial visit after physicist report.It is unknown why the dose levels were high when the physicist did the check.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT EXT DR FINAL ASSY-STANDARD
• 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: 5107600
• MDR Text Key: 27070816
• Report Number: 1518293-2015-00091
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• 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-STANDARD
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2014
• 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