FDA Adverse Event Injury Summary report: N

CUSTOM ULTRASONICS

MDR report key: 1883826 · Received October 22, 2010

Report

Report Number: 2523209-2010-00002
Event Type: Injury
Date Received: October 22, 2010
Date of Event: October 4, 2010
Report Date: October 19, 2010
Manufacturer: CUSTOM ULTRASONICS INC
Product Code: NVE
PMA / PMN Number: 983017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE SERVICE TECH ON ARRIVAL ON (B)(6) 2010 REPORTED THAT HE FOUND THE SYSTEM FUNCTIONING NORMALLY AND NO OVERHEATING OF THE DISINFECTANT REOCCURRED. COMPANY RECORDS ON THE SYSTEM WERE REVIEWED INDICATING THE SYSTEM WAS RELEASED FROM MFG ON 12/23/1997 INSTALLED AND IN-SERVICED AT THE HOSP JAN 1998. THE SYSTEM'S DATA BASE LOG INDICATES THE SYSTEM PERFORMED 23,925 CYCLES. AS FOR THE 23,925 CYCLES WHEN MULTIPLIED BY 85 FUNCTIONS PER CYCLE, THE SYSTEM PERFORMED SINCE 1998 2,033,626 COMPONENT FUNCTIONS. ON THE BASIS OF THIS INFO, THE HOSP ISSUED AN EMERGENCY PURCHASE FOR A NEW SYSTEM ON (B)(6) 2010. THE NEW SYSTEM WAS INSTALLED AND HOSP PERSONNEL TRAINED ON (B)(6).

Description of Event or Problem · 1

WE RECEIVED A PHONE CALL FROM MR (B)(6) ON (B)(6) 2010, AT (B)(6) INDICATING THE OPERATOR LEFT THE SYSTEM 83 ON OVER THE WEEKEND AND THE DISINFECTANT CIDEX BECAME OVERHEATED IN ITS RESERVOIR. ON OPENING THE LID COVERING THE RESERVOIR CONTAINING THE DISINFECTANT, FUMES WERE RELEASED INTO THE FACE OF THE OPERATOR. FOLLOWING THE PHONE CALL FROM MR (B)(6), THE SERVICE TECH FOR THAT AREA WAS CONTACTED BY PHONE AND DISPATCHED TO THE HOSP ARRIVING ON (B)(6) 2010 TO EVALUATE THE PROBLEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CUSTOM ULTRASONICS	ENDOSCOPE WASHER/DISINFECTOR	NVE	CUSTOM ULTRASONICS INC	SYSTEM 83+2	EQ#779

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Other