MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

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.

• Brand Name: AMSCO 400 STERILIZER
• Type of Device: STERILIZER
• 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 Key: 9495924
• MDR Text Key: 177154537
• Report Number: 3005899764-2019-00096
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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
• Date Manufacturer Received: 11/19/2019
• 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
• Patient Sequence Number: 1