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

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

There are no reported injuries associated with this event.The reported symptom relating to the ultrasonics failure to perform and the return of an obsolete connector is attributed to liquid ingress that caused a shorting condition of the three internal pins or wire within the connector, eliminating ultrasonics performance.

Event Description

During preventative maintenance, it was noticed that the ultrasonics were not functioning.

• Brand Name: SYSTEM 83 PLUS 2
• Type of Device: 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: 5364253
• MDR Text Key: 36288927
• Report Number: 3007082252-2016-00001
• 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: 01/11/2016

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: 12/17/2015
• Initial Date FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/1999
• 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