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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ;OEBE; F;ARSJEO, HUT EXT DR FINAL ASSY-STANDARD

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;OEBE; F;ARSJEO, HUT EXT DR FINAL ASSY-STANDARD Back to Search Results
Model Number HUT EXT DR FINAL A
Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953); Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2014
Event Type  malfunction  
Event Description
Customer reports via phone that during an undetermined urology procedure, the fluoro footswitch failed, and no fluoro image could be obtained.Physician completed the procedure by using rad imaging shots.Customer would not provide any further patient or procedural information other than to say the patient is fine.No reported injury.
 
Manufacturer Narrative
Tech service discussed with biomed intermittent issues he had.Biomed mentioned that he had repaired a bad x-ray footswitch and the fluoro image would intermittently fluctuate up and down.Tech service explanted that this could be caused by a number of items in the fluoro chain from the sedecal to the tube and back to the image intensifier (ii).On (b)(4), a field service engineer (fse) went on site and found the fluoro image was going and out of focus, the table display was blank, and the table motions were erratic.Fse troubleshot these issues and resolved them by replacing the 24v power supply to the table.Fse checked the system for proper operation per service checklist qssrwi4.1 and returned the unit to the customer for service.
 
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Brand Name
HUT EXT DR FINAL ASSY-STANDARD
Manufacturer (Section D)
;OEBE; F;ARSJEO,
2111 east galbraith rd.
cincinnati OH 45237
Manufacturer Contact
david benson
2111 east galbraith rd.
cincinnati, OH 45237
5139485719
MDR Report Key4095501
MDR Text Key21316903
Report Number1518293-2014-00105
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/19/2014
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 NumberHUT EXT DR FINAL A
Device Catalogue Number404008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/19/2014
Initial Date FDA Received09/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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