FDA Adverse Event Malfunction Summary report: N

AUTOFEED HUMIDIFICATION CHAMBER

MDR report key: 1841264 · Received September 14, 2010

Report

Report Number: 9611451-2010-00546
Event Type: Malfunction
Date Received: September 14, 2010
Date of Event: August 12, 2010
Report Date: August 12, 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

(B)(4). METHOD: THE RECEIVED DEVICE WAS 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 CONNECTOR OF THE FEEDSET SPIKE AND FEEDSET TUBE. THE WATER BAG TEST REVEALED WATER LEAKAGE AT THE JOINT OF THE WATER BAG SPIKE AND FEEDSET TUBE, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE 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 SYS AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PT." AS PART OF OUR ONGOING IMPROVEMENT, 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 BETWEEN THE SPIKE AND WATER FEEDSET TUBE ON AN MR290 AUTOFEED HUMIDIFICATION CHAMBER DURING SETUP, BEFORE PT USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AUTOFEED HUMIDIFICATION CHAMBER		BTT	FISHER & PAYKEL HEALTHCARE LTD	MR290	100220

Patients

Seq	Age	Sex	Outcome	Treatment
1