MAUDE Adverse Event Report: CUSTOM ULTRASONICS INC. SYSTEM 83 PLUS 2; ENDOSCOPE WASHER DISINFECTOR

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

There are no injuries associated with this event.The reported symptom for the returned ultrasonic generator (500 w) board was attributed to a faulty diode, on the ac input signal, within the bridge rectifier, brg1, on the ultrasonic generator (500 w) board, p/n 12008, causing the fuse to open, rendering the board inoperable.The rectifier failure is likely attributed to an over voltage or over current condition.

Event Description

While on site for repairs and ufas installation, it was noticed that the ultrasonics were not functioning.

• Brand Name: SYSTEM 83 PLUS 2
• Type of Device: ENDOSCOPE 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 Key: 6556626
• MDR Text Key: 74939945
• Report Number: 3007082252-2017-00010
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1