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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION AMSCO 400 SERIES; STERILIZER, STEAM
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STERIS CORPORATION AMSCO 400 SERIES; STERILIZER, STEAM Back to Search Results
Model Number 400 SERIES
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 06/30/2015
Event Type  Injury  
Event Description
The steam sterilizers had some bad water from a malfunctioning ro water system and caused the generators to fail.When the generators failed we were unable to efficiently run the machine, the steam generator was replaced.
 
Manufacturer Narrative
Unique device identifier (udi): for type of device: sterilizer, steam.
 
Event Description
The steam sterilizers had some bad water from a malfunctioning ro water system and caused the generators to fail.When the generators failed we were unable to efficiently run the machine, the steam generator was replaced.
 
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Brand Name
AMSCO 400 SERIES
Type of Device
STERILIZER, STEAM
Manufacturer (Section D)
STERIS CORPORATION
5960 heisley road
mentor OH 44060
MDR Report Key5460372
MDR Text Key39037046
Report Number5460372
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/06/2015,02/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number400 SERIES
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/06/2015
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer10/06/2015
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
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