FDA Adverse Event Malfunction Summary report: N

INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

MDR report key: 1741277 · Received June 29, 2010

Report

Report Number: 9611451-2010-00416
Event Type: Malfunction
Date Received: June 29, 2010
Report Date: June 29, 2010
Manufacturer: FISHER & PAYKEL HEALTHCARE LTD
Product Code: BZE
PMA / PMN Number: K034026
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). METHOD: ONE CIRCUIT WAS FOR LOT NUMBER 100114. NO LOT NUMBER WAS PROVIDED FOR THE SECOND CIRCUIT. THE RETURNED CIRCUITS WERE PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO CHECK FOR LEAKS. RESULTS: BOTH DEVICES WERE FOUND TO BE LEAKING AT THE SWIVEL. CONCLUSION: THE TWO PARTS THAT MAKE UP THE Y-SWIVEL ARE HELD TOGETHER BY A SNAP-FIT, WHICH HAS SOME INHERENT LEAKAGE THAT IS DETECTED AND COMPENSATED FOR BY THE VENTILATOR. IT IS POSSIBLE THAT IF NOT PROPERLY LOCKED INTO PLACE, THE LEAK BETWEEN THE SWIVEL JOINT WAS ENHANCED DURING TRANSPORT OR SETUP DESPITE HAVING PASSED THE LEAK TEST AT THE TIME OF PRODUCTION. ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR MONITORING AND TRENDING OF SWIVEL LEAKS INVOLVING INFANT EVAQUA BREATHING CIRCUITS HAS A RATE OF OCCURRENCE OF 92 UNITS PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO MAY 2010.

Description of Event or Problem · 1

A HOSPITAL IN (B)(6) REPORTED THAT TWO RT235 BREATHING CIRCUITS WERE LEAKING FROM THE "SWIVEL PART ON THE PATIENT END." THIS WAS FOUND BEFORE PATIENT USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT	BZE	BZE	FISHER & PAYKEL HEALTHCARE LTD	RT235	100114

Patients

Seq	Age	Sex	Outcome	Treatment
1