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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS BENCHMARK ULTRA
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VENTANA MEDICAL SYSTEMS BENCHMARK ULTRA Back to Search Results
Model Number 750-600
Device Problem Fluid/Blood Leak (1250)
Patient Problems Fall (1848); Injury (2348)
Event Date 02/26/2019
Event Type  malfunction  
Event Description
Instrument malfunction: tub overflow occurred and allowed fluid to reach floor.Tub sensor(s) did not properly report error and prevent fluid leak.The following failure mode is same event reported in mdr-2028492-2016-00004-00 which caused serious slip and fall injury.
 
Manufacturer Narrative
A us customer alleged leakage of the benchmark ultra instrument, which migrated to the floor.No harm or injury was indicated.The leak was cleaned by the customer site.The local service personnel visited the site, cleaned the waste filter and then performed the waste flow rate function test, which passed with no further errors.No leaks or other issues were noted during the inspection.These service actions remedied the customer's observation.A new waste tub and filter kit have been released to increase the reliability of the waste system.This is achieved by increasing the holding capacity of the waste tub and removing the inline waste filter.A new customer cleanable waste strainer has been created and added to the waste tub.(b)(4).
 
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Brand Name
BENCHMARK ULTRA
Type of Device
BENCHMARK ULTRA
Manufacturer (Section D)
VENTANA MEDICAL SYSTEMS
1910 e. innovation park dr.
tucson AZ 85755 1962
MDR Report Key8453643
MDR Text Key140127582
Report Number2028492-2019-00005
Device Sequence Number1
Product Code KPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number750-600
Device Catalogue Number05342716001
Device Lot Number313502
Date Manufacturer Received02/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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