FDA Adverse Event Malfunction Summary report: N

SYSTEM 83 PLUS 9

MDR report key: 5097728 · Received September 23, 2015

Report

Report Number: 3007082252-2015-00014
Event Type: Malfunction
Date Received: September 23, 2015
Date of Event: September 9, 2015
Report Date: September 9, 2015
Manufacturer: CUSTOM ULTRASONICS INC.
Product Code: FEB
PMA / PMN Number: K983017
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THERE ARE NO REPORTED INJURIES ASSOCIATED WITH THIS EVENT. THE REPORTED SYMPTOM RELATING A WHITE RESIDUE NOTED IN THE SYSTEM HLD RESERVOIR IS LIKELY ATTRIBUTED TO THE FACILITY WATER QUALITY (HARD WATER) AND INTERACTION WITH METRICIDE OPA PLUS WHICH CAN CREATE PRECIPITATES AS INDICATED IN THE HLD MANUFACTURER'S PRODUCT LABELING. THE REPORTED SYMPTOM RELATING TO A FAILURE OF THE ULTRASONICS NOT FUNCTIONING IN BAY 1 IS ATTRIBUTED TO LIQUID INGRESS ONTO THE TRANSDUCER CRYSTAL/NOSE AND TAIL PC ASSEMBLY, P/N 12061, CAUSING A SHORTING CONDITION THAT EVENTUALLY LED TO THE FAILURE OF THE ULTRASONIC GENERATOR (500 W) BOARD, P/N 12008, DATE CODE OCTOBER 04, 2000. THE CAUSE FOR THE LIQUID INGRESS COULD NOT BE DETERMINED.

Description of Event or Problem · 1

DURING USE, A WHITE RESIDUE WAS NOTED IN THE SYSTEM HLD RESERVOIR. THE CUSTOMER IS USING CIDEX OPA FOR HLD AND TERGAL 800 FOR DETERGENT. ADDITIONALLY, IT WAS NOTED BY THE FACILITY BIOMED DURING A FUNCTION TEST OF THE MACHINE TO VERIFY PERFORMANCE THAT THE ULTRASONICS IN BAY 1 WERE NOT FUNCTIONING AS INTENDED. BAY 2 ULTRASONICS ARE FUNCTIONING NORMALLY. SCOPES BEING PROCESSED AT THE TIME WERE PROCESSED ALTERNATIVELY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
628503	SYSTEM 83 PLUS 9	ENDOSCOPE WASHER AND DISINFECTOR	FEB	CUSTOM ULTRASONICS INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1