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

Model Number MR290V

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining the complaint mr290v vented autofeed humidification chamber from the healthcare facility.We will provide a follow-up report once we have received the complaint device and completed our investigation.

Event Description

A healthcare facility in austria reported to a fisher & paykel healthcare (fph) field representative that an mr290v vented autofeed humidification chamber was found leaking during set up.

Manufacturer Narrative

(b)(4).Event and awareness dates were changed to (b)(6) 2016.Method: the complaint mr290v vented autofeed humidification chamber was returned to fph (b)(4) and was visually inspected.Results: visual inspection revealed that the chamber dome was cracked underneath one of the ports.The crack was also showing stress marks.A lot check revealed no other complaints of this nature for lot number 160316.Conclusion: the healthcare facility reported that the subject mr290v chamber was used with a sipap ventilator.This type of ventilator is capable of producing pressures in excess of 80cmh2o.The integrity of the chamber can be affected when pressures exceed 80cmh2o.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: "use of the mr290 above the maximum operating pressure [8kpa (~80cmh2o)] may lead to cracking, water leakage and, on rare occasions could lead to a loss of ventilation pressure."; "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient."; "set appropriate ventilator alarm.".

Event Description

A healthcare facility in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that an mr290v vented autofeed humidification chamber was found leaking during set up.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 5870475
• MDR Text Key: 51937974
• Report Number: 9611451-2016-00425
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• 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: 160316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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