MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290V

Device Problem Filling Problem (1233)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) method: the complaint mr290v vented autofeed humidification chamber was returned to fisher and paykel healthcare in (b)(4) for investigation.The chamber was visually inspected and functionally tested.Results: visual inspection revealed no damage to the chamber.The floats were found to be moving freely.During the functional test the water level of both primary and secondary floats was checked.Both floats operated correctly and the water level attained was within specification.Conclusion: we were unable to determine the cause of the reported issue, as the complaint mr290 chamber was found to be operating correctly.All mr290 chambers have float function and valve testing performed twice during production.A failure of any test would result in rejection of the chamber before distribution.The user instructions that accompany the mr290 state the following: set appropriate ventilator alarms.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.

Event Description

A hospital in (b)(6) reported via a distributor that "water overflowed" from an mr290v humidification chamber during patient use.No patient consequence was reported.

• Brand Name: VENTED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7340502
• MDR Text Key: 102595172
• Report Number: 9611451-2018-00199
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 170911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1