FDA Adverse Event Other Summary report: N

SYSTEM 83 PLUS

MDR report key: 2851063 · Received November 20, 2012

Report

Report Number: 2523209-2012-00002
Event Type: Other
Date Received: November 20, 2012
Date of Event: August 23, 2012
Report Date: November 16, 2012
Manufacturer: CUSTOM ULTRASONICS
Product Code: KOG
PMA / PMN Number: K983017
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE SYSTEM 83 PLUS 2 WAS INSTALLED ON (B)(4) 2011. THE CUSTOM ULTRASONICS' SERVICE TECHNICIAN WAS INSTRUCTED TO SET THE PARAMETERS OF THE DISINFECTANT CIDEX OPA WITH A 5 MINUTE IMMERSION TIME. IN (B)(4) 2011, WHILE ON AN IN SERVICE CALL, THE CUSTOM ULTRASONICS TECHNICIAN WAS AGAIN ASKED TO SET THE PARAMETER TO METRICIDE OPA WITH A 5 MINUTE IMMERSION TIME. THE UNIT WAS NOT PUT INTO SERVICE UNTIL (B)(4) 2011. THE (B)(6) NOTIFIED CUSTOM ULTRASONICS THAT THE FACILITY HAS BEEN USING METRICIDE, A DISINFECTANT, WITH A RECOMMENDED 20 MINUTE IMMERSION TIME WHILE THE MACHINE WAS SET FOR A 5 MINUTE IMMERSION TIME. THE SYSTEM 83 PLUS 2 HAS BEEN OPERATING IN THIS SITUATION SINCE (B)(6) 2011. CUSTOM ULTRASONICS INC. WAS NOT NOTIFIED TO CHANGE THE PARAMETER SETTINGS UNTIL (B)(4) 2012. AT THAT TIME, A SERVICE TECHNICIAN WAS DISPATCHED TO ADJUST THE TIME SETTINGS. A RISK ASSESSMENT CONDUCTED BY CUSTOM ULTRASONICS' (B)(4), DATED (B)(4) 2012, WAS SENT TO THE USER FACILITY. THERE WERE NO PATIENT INJURIES REPORTED.

Description of Event or Problem · 1

CUSTOMER ULTRASONICS INC. WAS INFORMED BY A USER FACILITY THAT THE FACILITY IS USING THE INCORRECT DISINFECTANT PARAMETERS FOR METRICIDE (GLUTARALDEHYDE 14 DAY) DISINFECTANT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYSTEM 83 PLUS	ENDOSCOPE ACCESSORY	KOG	CUSTOM ULTRASONICS	SYSTEM 83 PLUS 2

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other