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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 5052 WASHER

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STERIS CANADA CORPORATION AMSCO 5052 WASHER Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
The facility could not provide a specific date of event or incident that attributed to the reported postponed procedures.We are dispatching a service technician to work with the customer on the issues they are experiencing so as to assist with the operation of the unit.Our evaluation to-date has not identified an issue.The washer was installed in march 2016 and is under steris service agreement for maintenance activities.The last regularly scheduled preventive maintenance was performed on february 5, 2020; no repairs were made at that time, and the unit was confirmed to be operating according to specifications.A follow-up mdr will be submitted when additional information becomes available.
 
Event Description
The user facility reported their amsco 5052 washer was not operating properly resulting in postponed procedures.
 
Manufacturer Narrative
The user facility elected to replace the washer.The replacement washer was installed, tested, and confirmed to be operating according to specifications.The washer is not being returned to steris for evaluation.The last preventive maintenance was performed on february 5, 2020; no repairs were made at the time and the unit was confirmed to be operating according to specification.No additional issues have been reported.
 
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Brand Name
AMSCO 5052 WASHER
Type of Device
WASHER
Manufacturer (Section D)
STERIS CANADA CORPORATION
490 armand-paris
quebec, GIC 8 A3
CA  GIC 8A3
MDR Report Key9830934
MDR Text Key196002363
Report Number9680353-2020-00011
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Initial Date Manufacturer Received 02/12/2020
Initial Date FDA Received03/13/2020
Supplement Dates Manufacturer Received02/12/2020
Supplement Dates FDA Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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