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

Model Number MR290V

Device Problems Air Leak (1008); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290 vented autofeed humidification chamber is expected, but has not yet been returned to fisher & paykel healthcare in (b)(4).We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported via a fisher & paykel healthcare field representative that the mr290v vented humidification chamber was leaking.This was found before use on a patient.

Event Description

A distributor in colombia reported via a fisher & paykel healthcare field representative that the mr290v vented autofeed humidification chamber was leaking.This was found before use on a patient.

Manufacturer Narrative

(b)(6).The complaint mr290 autofeed humidification chamber was not returned to fisher & paykel healthcare in new zealand for evaluation.Without examining the complaint device we are unable to confirm a fault with the device.The distributor reported that the subject mr290 chamber has a leak.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome due to cracks and other causes.In addition, the pressure test is followed by a visual inspection of each chamber.Any chamber which fails either of these tests is rejected.The chamber would have met the required specification at the time of production.Our user instructions that 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." - "set appropriate ventilator alarm.".

• 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
• MDR Report Key: 7485920
• MDR Text Key: 107721464
• Report Number: 9611451-2018-00361
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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: 2100214806
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1