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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. AMSCO 400 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER Back to Search Results
Device Problem Defective Component (2292)
Patient Problem No Information (3190)
Event Date 10/14/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event. During his inspection, the technician felt a minor shock after touching the casing of the control panel of the sterilizer door. The technician was not injured and no medical treatment was sought or administered. While onsite, the technician was informed that the door lock assembly, including the wiring for the door sensor, had recently been replaced by the user facility's biomed department. The technician found that the wiring for the door lock assembly was pinched subsequently causing the insulation of the wiring to become frayed. The exposed wiring contacted the frame of the control panel resulting in an electrical short and the reported event. The unit was installed in 2016 and is not under steris service agreement; the user facility is responsible for all maintenance activities. The reported event is attributed to improper maintenance activities by the biomed department. The amsco 400 sterilizer operator manual states (1-3), "warning - personal injury hazard and/or equipment damage hazard: repairs and adjustments to this equipment must be made only by fully qualified service personnel. Maintenance performed by inexperienced, unqualified persons or installation of unauthorized parts could cause personal injury or result in costly equipment damage. " the technician performed the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service. The technician counseled the biomed department on proper maintenance activities, specifically replacement of the door lock assembly. No additional issues have been reported.
 
Event Description
The user facility reported an issue with their amsco 400 sterilizer following repairs performed by the user facility's biomed department.
 
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Brand NameAMSCO 400 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 Key9286851
MDR Text Key199551961
Report Number3005899764-2019-00087
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 11/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received10/14/2019
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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