FDA Adverse Event Malfunction Summary report: N

VENTED AUTOFEED CHAMBER

MDR report key: 1843232 · Received September 24, 2010

Report

Report Number: 9611451-2010-00576
Event Type: Malfunction
Date Received: September 24, 2010
Date of Event: August 31, 2010
Report Date: August 31, 2010
Manufacturer: FISHER & PAYKEL HEALTHCARE LTD
Product Code: BTT
PMA / PMN Number: K934140
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

METHOD: THE TWO RETURNED COMPLAINT DEVICES WERE VISUALLY INSPECTED AND CONNECTED TO A WATER BAG TO CHECK FOR LEAKS. RESULTS: THE VISUAL INSPECTION FOUND THAT INSUFFICIENT GLUE HAD BEEN APPLIED BETWEEN THE CONNECTION OF THE FEEDSET SPIKE AND TUBE OF BOTH DEVICES. THE WATER BAG TEST REVEALED WATER LEAKAGE AT THE JOINT OF THE WATER BAG SPIKE AND FEEDSET TUBE, CONFIRMING THE REPORTED FAULTS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." AS PART OF OUR ONGOING PRODUCT IMPROVEMENTS, ADDITIONAL GLUE IS NOW APPLIED TO THE FEEDSET SPIKE DURING PRODUCTION. (B)(4).

Description of Event or Problem · 1

A HOSPITAL IN (B)(6) REPORTED THAT THEY FOUND LEAKAGE AROUND THE WATER FEEDSET TUBE, JUST BELOW THE SPIKE ADAPTOR OF TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS. THIS WAS FOUND PRIOR TO PATIENT USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VENTED AUTOFEED CHAMBER	BTT	BTT	FISHER & PAYKEL HEALTHCARE LTD	MR290	100324

Patients

Seq	Age	Sex	Outcome	Treatment
1