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

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onsite, the technician was informed that the door lock assembly, including the wiring for the door sensor, had recently been replaced by the user facility's biomed department.The technician found that the wiring for the door lock assembly was pinched subsequently causing the insulation of the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.

• 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: 9286851
• MDR Text Key: 199551961
• Report Number: 3005899764-2019-00087
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• 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: 10/14/2019
• 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
• Patient Sequence Number: 1