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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX STERILIZER
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STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX STERILIZER Back to Search Results
Device Problem Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2014
Event Type  No Answer Provided  
Event Description
The user facility reported that during an empty cycle smoke was emitting from the bottom of their v-pro max sterilizer.The fire department was dispatched and the sterile processing department was evacuated.No injuries or procedural delay or cancellations were reported.
 
Manufacturer Narrative
A steris service technician inspected the sterilizer and found oil residue in the f15 and f16 cartridges/filters.The technician cleaned the residual oil, replaced f15 and f16 cartridges and o-rings, ran multiple test cycles and confirmed the sterilizer to be operating properly.No additional issues have been reported.The sterilizer was installed on (b)(4) 2014 and is under steris warranty.
 
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Brand Name
V-PRO MAX STERILIZER
Type of Device
STERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 6719 0
MX  67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 6719 0
MX   67190
Manufacturer Contact
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key4276951
MDR Text Key5005644
Report Number3005899764-2014-00118
Device Sequence Number1
Product Code MLR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2014
Was Device Evaluated by Manufacturer? Yes
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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