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

Model Number MR290V

Device Problems Filling Problem (1233); Device Operational Issue (2914)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information to determine if the complaint mr290v vented autofeed humidification chambers had a malfunction which might have led to the reported event.We will provide a follow up report once we have completed our evaluation.

Event Description

A customer in the (b)(6) reported via a healthcare facility that three mr290 vented autofeed humidification chambers were not filling from the water bags after two weeks of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint mr290 vented autofeed humidification chambers were not returned to fisher & paykel healthcare for evaluation.An attempt was made to obtain the complaint devices or additional information regarding the reported fault but no information was received.Following production, the float mechanism of every mr290 chamber is performance tested and those that fail are rejected.The user instructions illustrate in pictorial format the correct set-up and proper use of the mr290 vented autofeed humidification chamber.It also state the following: "ensure there is a water supply connected to the chamber and that water is present within the chamber." "set appropriate ventilator alarm." without the complaint mr290 chambers, we are unable to establish the root cause of the reported fault.

Event Description

A customer in the (b)(6) reported via a healthcare facility that three mr290 vented autofeed humidification chambers were not filling from the water bags after two weeks of use.No patient consequence was reported.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• 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: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5613864
• MDR Text Key: 44494163
• Report Number: 9611451-2016-00177
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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