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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Death  

Manufacturer Narrative

Custom ultrasonics is not aware of a cu device being in service at this location, as alleged in the legal documents.

Event Description

Adverse event as alleged solely in legal documents.

• Brand Name: SYSTEM 83 PLUS
• Type of Device: ENDOSCOPE WASHER DISINFECTOR
• Manufacturer (Section D): CUSTOM ULTRASONICS, INC.; 144 railroad drive; ivyland PA 18974
• Manufacturer Contact: mario infanti ; 144 railroad drive; ivyland, PA 18974 ; 2153641477
• MDR Report Key: 6501054
• MDR Text Key: 233691971
• Report Number: 3007082252-2016-00039
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2016
• Initial Date FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male