FDA Adverse Event Malfunction Summary report: N

VENTED AUTOFEED CHAMBER

MDR report key: 2143923 · Received June 29, 2011

Report

Report Number: 9611451-2011-00383
Event Type: Malfunction
Date Received: June 29, 2011
Date of Event: May 10, 2011
Report Date: June 3, 2011
Manufacturer: FISHER & PAYKEL HEALTHCARE LTD
Product Code: BTT
PMA / PMN Number: K934140
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). METHOD: TWO CHAMBERS WERE RETURNED FOR EVALUATION; ONE FROM LOT 101220 AND ONE FROM LOT 101215. THE TWO RETURNED COMPLAINT CHAMBERS WERE PRESSURE TESTED. RESULTS: THE PRESSURE TEST REVEALED THAT BOTH CHAMBERS WERE WITHIN SPECIFICATION. THE FAILURE MODE AS REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 101220 BUT NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 101215. CONCLUSION: WE COULD FIND NO FAULT WITH THE COMPLAINT CHAMBERS. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

Description of Event or Problem · 1

A HOSPITAL IN (B)(6) REPORTED THROUGH OUR DISTRIBUTOR THAT WATER LEAKED FROM TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS AFTER USE. NO PATIENT CONSEQUENCE WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VENTED AUTOFEED CHAMBER	AUTOFEED CHAMBER	BTT	FISHER & PAYKEL HEALTHCARE LTD	MR290V	101220

Patients

Seq	Age	Sex	Outcome	Treatment
1