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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - DISTRIBUTION CENTER CREST ULTRASONIC CONSOLE; CREST SONIC
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STERIS CORPORATION - DISTRIBUTION CENTER CREST ULTRASONIC CONSOLE; CREST SONIC Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problems Fall (1848); Injury (2348)
Event Date 03/18/2015
Event Type  No Answer Provided  
Event Description
The user facility reported their crest ultrasonic console was leaking water onto the floor.An employee slipped on the water, fell, and sought medical treatment for knee pain.No report of procedural delay or cancellation.
 
Manufacturer Narrative
A steris field service technician arrived onsite, inspected the unit, and identified a crack on the side of the adapter at the soap injection area.Water was able to escape through the crack and leak onto the floor.The technician replaced the adapter and fittings, tested the unit, and returned the unit to service.The employee subject of the reported event did not miss work due to the reported injury.
 
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Brand Name
CREST ULTRASONIC CONSOLE
Type of Device
CREST SONIC
Manufacturer (Section D)
STERIS CORPORATION - DISTRIBUTION CENTER
6100 heisley rd
mentor OH 44060
Manufacturer Contact
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key4681930
MDR Text Key20068301
Report Number3003950207-2015-00002
Device Sequence Number1
Product Code FLG
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 04/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2015
Was Device Evaluated by Manufacturer? Yes
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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