FDA Adverse Event Malfunction Summary report: N

SYSTEM 83 PLUS 9

MDR report key: 3464112 · Received September 7, 2013

Report

Report Number: 2523209-2013-00012
Event Type: Malfunction
Date Received: September 7, 2013
Date of Event: September 5, 2013
Report Date: September 5, 2013
Manufacturer: CUSTOM ULTRASONICS INC.
Product Code: FLG
PMA / PMN Number: K122172
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VT, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ON (B)(4) 2013 CUSTOM ULTRASONICS RECEIVED A COMPLAINT STATING THAT THE ULTRASONIC SOUND WAVES WERE NOT FUNCTIONING ON THE SYSTEM 83 PLUS 9 UNIT (SERIAL NUMBER (B)(4)). CUSTOM ULTRASONICS DISPATCHED A TECHNICIAN TO (B)(6) ON (B)(6) 2013. THE HOSPITAL CONFIRMED THE TIME LINE ASSOCIATED WITH THIS ISSUE WAS SOMETIME AFTER (B)(6) 2013 THROUGH (B)(6) 2013, WHEN THE UNIT WAS TAKEN OUT OF SERVICE. CUSTOMER ULTRASONICS' INVESTIGATION REVEALED THAT THE WIRING WAS NOT HARNESSED ACCORDING CUSTOM ULTRASONICS SPECIFICATION. THE CAUSE OF THE BLOWN FUSE MAY HAVE BEEN ATTRIBUTED TO A SHORT CIRCUIT DUE TO WIRES NOT CORRECTLY HARNESSED. THE GENERATOR BOARD THAT HOUSES THE FUSE WAS REPLACED. THE CU TECHNICIAN DID DRESS THE WIRING CONFIGURATION ACCORDING TO THE FACILITY'S DIRECTION. THE CUSTOMER STATED TO DATE THERE HAVE BEEN NO REPORTED INJURIES. THE CUSTOMER REQUESTED A RISK ASSESSMENT OF THE CLEANING EFFECTIVENESS WITHOUT THE ULTRASONIC FUNCTION BEFORE MAKING A DETERMINATION TO NOTIFY THEIR PATIENTS. THERE MAY BE A LOW RISK OF INFECTION ASSOCIATED THE THIS ISSUE AS STATED IN THE RISK ASSESSMENT. CUSTOM ULTRASONICS INC IS REPORTING THIS INCIDENT OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

FUSE BLOWN ON GENERATOR BOARD CAUSING ULTRASONIC SOUND WAVES NOT TO FUNCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
445332	SYSTEM 83 PLUS 9	WASHER - DISINFECTOR	FLG	CUSTOM ULTRASONICS INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1