MAUDE Adverse Event Report: CUSTOM ULTRASONICS, INC.SYSTEM 83+2ULTRASONIC MEDICAL EQUIPMENT CLEANER

Model Number 83+2

Event Date 02/04/2004

Event Type  Malfunction  

Manufacturer Narrative

The investigation included contacting the user facility with the system. It was reported to custom ultrasonics that no mdr reports had been filed by the user facility, and that they were pleased with their custom ultrasonics systems. This information was reported by the infection control administrator who is also responsible for filing mdrs. The incident that occurred in 2004 with the system (maude report) with the same event description was addressed via custom ultrasonic's mdr 2523209-2007-00012. Review of complaint records did not reveal any other incidents for the same day. This incident appears to be duplicate of maude report.

Event Description

Custom ultrasonics (cu) has been notified of report (via maude) of a "possible adapter failure" that occurred more than four years ago. The text of the report matches that of maude report number with the same system serial number. Report had been responded to via mdr 2523209-2007-00012. This incident appears to be duplicate of report. Unfortunately, this report does not provide any means for cu to contact the individual reporter to follow-up and confirm this report. Without the ability to follow-up, cu is not sure if this information reasonably suggests that a serious injury or device malfunction actually occurred. Nonetheless, we are reporting this incident out of an abundance of caution.

• Brand Name: SYSTEM 83+2
• Type of Device: ULTRASONIC MEDICAL EQUIPMENT CLEANER
• Manufacturer (Section F): CUSTOM ULTRASONICS, INC.; 144 railroad drive; ivyland PA 18974
• Manufacturer (Section D): CUSTOM ULTRASONICS, INC.; 144 railroad drive; ivyland PA 18974

Manufacturer (Section G)

• Manufacturer Contact: anika tsimberg, qa director, ; 144 railroad drive; ivyland , PA 18974; (215) 364 -1477
• Device Event Key: 1005087
• MDR Report Key: 1005542
• Event Key: 940039
• Report Number: 2523209-2008-00002
• Device Sequence Number: 1
• Product Code: FLG
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2008

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/29/2008
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: No
• Device Operator: Service Personnel
• Device MODEL Number: 83+2
• Is The Reporter A Health Professional?: No
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 02/12/2008
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 02/05/1998
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Invalid Data