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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 Device Alarm System (1012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following each reported event to inspect the amsco 400 sterilizer. The technician was informed per user facility personnel that the i/o board #01 failure alarm would go off intermittently making the unit unavailable to use. After continuous investigation and support from steris engineering, the root cause of the reported events were attributed to the unit's i/o board. The i/o board was damaged due to a water leak from the facility. Piping that is owned by the facility was cracked, allowing water to leak out onto the sterilizer's i/o board causing the reported event to occur. The technician replaced the i/o board, ran a test cycle, found the unit to be operating according to specification, and returned it to service. Steris evaluated the reported events and determined none of the four meet our reporting criteria under 21 cfr part 803. It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures. No additional issues have been reported. - (b)(4).

 
Event Description

The user facility reported via medwatch # (b)(4) that their amsco 400 sterilizer was alarming "i/o board #01 failure". 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 Key9495924
MDR Text Key177154537
Report Number3005899764-2019-00096
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 12/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2019
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 Received11/19/2019
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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