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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM; STERILIZER, CHEMICAL
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STERIS CORPORATION AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM; STERILIZER, CHEMICAL Back to Search Results
Model Number V PRO MAX
Device Problems Electrical /Electronic Property Problem (1198); Fire (1245); Smoking (1585)
Patient Problems Irritation (1941); Respiratory Distress (2045)
Event Date 03/02/2017
Event Type  malfunction  
Event Description
A short electrical fire in the vpro - low temp stabilizer broke out, causing smoke and soot in cp area.Fire department responded.Four associates required care for irritation in their throat.Three orthopedic surgical cases had to be rescheduled.A sterilizing cycle had been started, cp colleagues noticed smoke in central processing (cp) and alarmed the bell.The sterilizer essentially contained/suppressed the fire however there was soot/smoke throughout the once-sterile environment of cp requiring a terminal cleaning of 100% of cp and removal/destruction of all "soft" materials or product that cannot be sterilized.Manufacturer response for sterilizer chemical, (brand not provided) (per site reporter): unk.
 
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Brand Name
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
Type of Device
STERILIZER, CHEMICAL
Manufacturer (Section D)
STERIS CORPORATION
5960 heisley rd.
mentor OH 44060
MDR Report Key6431677
MDR Text Key70795988
Report Number6431677
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV PRO MAX
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2017
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer03/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO DIRECT USE ON PATIENT HOWEVER THE FIRE IN CENTR
Patient Outcome(s) Other;
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