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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC VENTANA HE 600 SYSTEM; SLIDE STAINER, AUTOMATED
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VENTANA MEDICAL SYSTEMS INC VENTANA HE 600 SYSTEM; SLIDE STAINER, AUTOMATED Back to Search Results
Catalog Number 06917259001
Device Problems Display or Visual Feedback Problem (1184); Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problems Fall (1848); Pain (1994)
Event Date 12/18/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation is ongoing.A supplemental mdr will be submitted upon completion of the investigation.(b)(4).
 
Event Description
A customer from the us reported receiving 2 error messages from the instrument.The instrument leaked and the technician slipped and fell.The technician went to urgent care and reported aches and soreness from the fall.Follow up visit to urgent case confirmed no broken bone.
 
Manufacturer Narrative
Investigation found that the the pcba fpga based gpio svc (07369280001) failed which causes the affected reagent pump to run continuously causing an overflow into the air system.Fluid spilled onto the floor causing a lab team member to slip and fall.The failed gpio pcb was requested for investigation but was accidently discarded at the customer site, therefore, investigation of the failed component is not possible.Cn-568326.
 
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Brand Name
VENTANA HE 600 SYSTEM
Type of Device
SLIDE STAINER, AUTOMATED
Manufacturer (Section D)
VENTANA MEDICAL SYSTEMS INC
1910 e innovation park dr
tucson AZ 85755
MDR Report Key11176673
MDR Text Key228214622
Report Number2028492-2021-00001
Device Sequence Number1
Product Code KPA
Combination Product (y/n)N
PMA/PMN Number
510K EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number06917259001
Date Manufacturer Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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