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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 48" PLATFORM STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 48" PLATFORM STERILIZER Back to Search Results
Device Problem Device Fell (4014)
Patient Problem Injury (2348)
Event Date 04/17/2019
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the platform sterilizer. The technician identified that one of the screws that holds the magnet bracket in place was lose, allowing the bracket to move out of place and not properly attach to the sterilizer. The vibration of the door being opened by the employee caused the panel to fall and the reported event to occur. The technician made the necessary repairs, including securing the bracket, and realigning the magnets and returned the unit to service. No additional issues have been reported.

 
Event Description

The user facility reported that the access panel located at the bottom of the platform sterilizer fell and hit an employee's foot. Medical treatment was administered.

 
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Brand Name48" PLATFORM STERILIZER
Type of DeviceSTERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key8613673
MDR Text Key145237073
Report Number3005899764-2019-00050
Device Sequence Number1
Product Code FLE
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 05/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
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

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