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

Model Number MR290V

Device Problems Hole In Material (1293); Device Handling Problem (3265)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr290 chamber is currently en route to fisher & paykel healthcare (b)(4) for evaluation.We are in the process to determine if fph's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A customer in the usa reported that the mr290v humidification chamber would develop holes on the bottom of the chamber after 21 to 24 days.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Lot# 160829, manufactured date: 29 aug 2016,(b)(4).Lot #161107 manufactured date: 07 nov 2016, (b)(4).Method: two complaint mr290v humidification chambers (device #1: lot 160829, device #2: 161107) were returned to fph (b)(4) for investigation.The mr290 chambers were visually inspected and residue found on the mr290 chambers was analysed with scanning electron microscopy with x-ray microanalysis (sem-eds).Result: visual inspection revealed that the base of chambers #1 and #2 were eroded on the inside and outside of both chambers.The chamber bases were found eroded and holes were found where the base was eroded.Residue was found on the inside and outside of the chambers.The residue was further investigated by sem-eds analysis, which revealed that the residue contained sodium compounds, which are of external origin and that are commonly used in cleaning agents.Conclusion: the residue suggest that the damage was caused by the chamber coming into contact with a cleaning solution which has very likely caused the reported damage to the chamber dome.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.Moreover, analysis of the residue revealed that it was of external origin and likely a chemical substance that is used in cleaning agents.Our user instructions that accompany the mr290v humidification chambers state the following: - do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.- perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.- set appropriate ventilator alarms.

Event Description

A customer in the usa reported that the mr290v humidification chamber would develop holes on the bottom of the chamber after 21 to 24 days.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: irfanali kermalli ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6488991
• MDR Text Key: 72933135
• Report Number: 9611451-2017-00326
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

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: Lay User/Patient
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• 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
• Treatment: TRILOGY 100 VENTILATOR