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U.S. Department of Health and Human Services

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

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CUSTOM ULTRASONICS, INC. SYSTEM 83 PLUS WASHERS, FLEXIBLE ENDOSCOPE Back to Search Results
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.

 
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Brand NameSYSTEM 83 PLUS
Type of DeviceWASHERS, FLEXIBLE ENDOSCOPE
Manufacturer (Section F)
CUSTOM ULTRASONICS, INC.
buckingham PA 18912
Manufacturer (Section D)
CUSTOM ULTRASONICS, INC.
buckingham PA 18912
Device Event Key501168
MDR Report Key512172
Event Key485938
Report NumberMW1031084
Device Sequence Number2
Product CodeFEB
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 Received02/03/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSYSTEM 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

Patient TREATMENT DATA
Date Received: 02/03/2004 Patient Sequence Number: 1
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