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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION RELIANCE SYNERGY; DISINFECTOR, MEDICAL DEVICES

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STERIS CORPORATION RELIANCE SYNERGY; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Device Problem Difficult to Open or Close (2921)
Patient Problem No Information (3190)
Event Date 10/20/2015
Event Type  malfunction  
Event Description
The doors on the instrument washer would not open.
 
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Brand Name
RELIANCE SYNERGY
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
STERIS CORPORATION
5960 heisley road
mentor OH 44060
MDR Report Key5182979
MDR Text Key29748982
Report Number5182979
Device Sequence Number1
Product Code MEC
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 10/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Nurse
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2015
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer10/21/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
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