MAUDE Adverse Event Report: CUSTOM ULTRASONICS, INC.SYSTEM 83 PLUSWASHERS, FLEXIBLE ENDOSCOPE

Model Number SYSTEM 83 PLUS

Event Date 02/01/2004

Event Type  Malfunction  

Event Description

Reporter has experienced two like scope washing machines changing their chemical immersion time, detergent name, and disinfectant chemical name control parameters, apparently without user input. These control parameters, are independently set and stored for each of the three instrument bays on each machine. On further investigation reporter has verified, and can readily duplicate what is apparently a software flaw in the custom ultrasonics software. The identified problem manifests itself by setting the detergent name, disinfectant chemical name, chemical immersion time and perhaps other control parameters for a given scope processing bay to the values contained in the last printed historical record for that processing bay after having reviewed and printed that record on the screen. The change to the chemical immersion time happens regardless of whether or not it violates the minimum disinfectant time set for that processing bay. For example, reporter has observed and can duplicate the preset chemical immersion time changing from 20 minutes to 1 minute despite the minimum chemical immersion time being set at 20 minutes. The minimum disinfect time is a failsafe setting that is intended to prevent the operator from selecting an unsafe chemical immersion time and this setting can not be changed by the operator. The chemical immersion time is a user adjustable time that is intended to allow them to extend the chemical immersion time beyond the set minimum time but never below the minimum disinfect time setting. This problem has been reported to, and demonstrated for the manufacturer's service and sales representatives on three separate machines with two different software revisions.

• Brand Name: SYSTEM 83 PLUS
• Type of Device: WASHERS, FLEXIBLE ENDOSCOPE
• Manufacturer (Section F): CUSTOM ULTRASONICS, INC.; buckingham PA 18912
• Manufacturer (Section D): CUSTOM ULTRASONICS, INC.; buckingham PA 18912
• Device Event Key: 501168
• MDR Report Key: 512172
• Event Key: 485938
• Report Number: MW1031084
• Device Sequence Number: 2
• Product Code: FEB
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2004
• 3 DeviceS WERE Involved in the Event: 1 2 3

1 Patient Was Involved in the Event

• Date FDA Received: 02/03/2004
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device MODEL Number: SYSTEM 83 PLUS
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Event Location: Hospital
• Was The Report Sent To Manufacturer?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No
• Is this an Explanted Device?: No Answer Provided