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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 Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2019
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the amsco 400 sterilizer. The technician inspected the unit and found the sterilizer to be operating according to specification. No issues with the function or operation of the unit were found. No repairs were required, and the unit was returned to service. The facility confirmed the biological indicator and chemical indicator in the cycle subject of the reported event evidenced passing results. During discussion with user facility personnel, the technician was informed that after the successfully completed cycle, an employee removed the load from the sterilizer and placed the instrument pack on a shelf located directly under an air conditioning vent. The root cause of the event can be attributed to user error. Facility personnel did not follow proper storage practices per the amsco 400 sterilizer operator manual, resulting in the reported moisture. The amsco 400 sterilizer operator manual (pg. 6-4) states: "to prevent condensation, do not place load on a cold surface. Be sure that no air conditioning or cold air vents are in close proximity. " the technician counseled the user facility on the proper use and operation of the sterilizer specifically, ensuring the customer is storing processed loads properly. No additional issues have been reported.

 
Event Description

The user facility reported that after a patient had been put under anesthesia, the pack containing the instruments to be used in the procedure was brought into the or. At that time, user facility personnel identified there to be moisture inside the pack. The patient was brought out of anesthesia and the procedure was postponed as the instruments had to be reprocessed; the facility had no additional instruments available for use. No report of injury.

 
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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 Key8871501
MDR Text Key199549423
Report Number3005899764-2019-00073
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 08/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received07/08/2019
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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