FDA Adverse Event Injury Summary report: N

*

MDR report key: 886427 · Received July 6, 2007

Report

Report Number: 2523209-2007-00030
Event Type: Injury
Date Received: July 6, 2007
Report Date: June 6, 2007
Manufacturer: CUSTOM ULTRASONICS, INC.
Product Code: FLG
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

CU HAS CROSS-CHECKED THE ALLEGATION OF A MACHINE POSSIBLY ON "WASH ONLY" INSTEAD OF "WASH/DISINFECT" CYCLE AGAINST ITS COMPLAINT FILES AND HAS FOUND PRIOR INSTANCES OF THE REPORTED PROBLEM CAUSED BY USER ERROR. SINCE THE TIME OF THIS EVENT, CU HAS ADDED A SOFTWARE FEATURE THAT REQUIRES CONFIRMATION OF USER INPUT AS PART OF THE EVOLUTION OF ITS PRODUCTS.

Description of Event or Problem · 1

AS PART OF A REVIEW OF MEDWATCH REPORTS AVAILABLE ON THE MAUDE DATABASE, CUSTOM ULTRASONICS (CU) HAS LEARNED OF REPORT OF A MACHINE POSSIBLY ON "WASH ONLY" INSTEAD OF "WASH/DISINFECT" CYCLE. UNFORTUNATELY, THIS REPORT DOES NOT PROVIDE ANY MEANS FOR CU TO CONTACT THE REPORTER OR FACILITY TO FOLLOW-UP AND CONFIRM THIS REPORT. WITHOUT THE ABILITY TO FOLLOW-UP, CU IS NOT SURE IF THIS INFO REASONABLY SUGGESTS THAT A SERIOUS INJURY OR DEVICE MALFUNCTION ACTUALLY OCCURRED. NONETHELESS, WE ARE REPORTING THIS INCIDENT OUT OF AN ABUNDANCE OF CAUTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	*	ULTRASONIC MEDICAL EQUIPMENT CLEANER	FLG	CUSTOM ULTRASONICS, INC.	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	*		Other