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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION AMSCO; DISINFECTOR, MEDICAL DEVICES
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STERIS CORPORATION AMSCO; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number 5052
Device Problems Break (1069); Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2019
Event Type  malfunction  
Event Description
Received report from our central services team that their washer was leaking.After extensive inspection of device, it was indicated that there was a potential bad door gasket.Gasket was replaced.Washer continued to leak so mfg service was called.Mfg service representative thought the door gasket may have been faulty and ordered/installed a replacement door gasket.Replacement gasket also failed.After further investigation, it was determined there was a weld failure.The mfg came back in and drilled and tapped 8 holes to repair the broken weld.Manufacturer response for washer/decontaminators, (brand not provided) (per site reporter).Mfg installed a weld repair kit.
 
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Brand Name
AMSCO
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
STERIS CORPORATION
5960 heisley rd
mentor OH 44060
MDR Report Key9255697
MDR Text Key164299719
Report Number9255697
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number5052
Device Catalogue NumberFH14
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/20/2019
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer10/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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