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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7053HP WASHER/DISINFECTOR

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STERIS CANADA ULC AMSCO 7053HP WASHER/DISINFECTOR Back to Search Results
Model Number 7053HP
Device Problem Leak/Splash (1354)
Patient Problem Concussion (2192)
Event Date 01/06/2023
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the washer and found that the fittings below the flow meters were loose resulting in liquid leaking onto the floor.The technician removed, cleaned, and retightened the fittings, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.
 
Event Description
The user facility reported that an employee slipped and fell on soap leaking from their amsco 7053hp washer/disinfector resulting in an injury (concussion).The employee sought and received medical treatment.
 
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Brand Name
AMSCO 7053HP WASHER/DISINFECTOR
Type of Device
WASHER/DISINFECTOR
Manufacturer (Section D)
STERIS CANADA ULC
490 boulevard armand-paris
quebec, G1C 8 A3
CA  G1C 8A3
Manufacturer (Section G)
STERIS CANADA ULC
490 boulevard armand-paris
quebec, G1C 8 A3
CA   G1C 8A3
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key16396116
MDR Text Key310161625
Report Number9680353-2023-00007
Device Sequence Number1
Product Code MEC
UDI-Device Identifier00724995176662
UDI-Public00724995176662
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 02/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number7053HP
Device Catalogue NumberFH19042
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2019
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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