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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 9 ENDOSCOPE WASHER DISINFECTOR

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CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 9 ENDOSCOPE WASHER DISINFECTOR Back to Search Results
Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 09/03/2015
Event Type  Malfunction  
Manufacturer Narrative

There are no reported injuries associated with this event. The reported symptom relating to a failure of the ultrasonics not functioning is attributed to liquid ingress onto the ultrasonic generator (500 w) board, p/n 12008, date code november 19, 2009 and the transducer crystal/nose and tail pc assembly, p/n 12061, causing a shorting condition that led to the failure. The liquid ingress was caused by the leak found during the preventative maintenance between the return and the high level disinfectant reservoir.

 
Event Description

While on site for a scheduled preventative maintenance, it was noticed that the ultrasonics were not functioning, as well as, a leak was noted dripping onto the ultrasonic generator enclosure.

 
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Brand NameSYSTEM 83 PLUS 9
Type of DeviceENDOSCOPE WASHER DISINFECTOR
Manufacturer (Section D)
CUSTOM ULTRASONICS INC.
144 railroad drive
ivyland PA 18974
Manufacturer Contact
elizabeth lazaro
144 railroad drive
ivyland, PA 18974
2153641477
MDR Report Key5105054
MDR Text Key26963646
Report Number3007082252-2015-00013
Device Sequence Number1
Product Code FEB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK983017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/06/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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