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

Model Number MR290V

Device Problems Hole In Material (1293); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was returned to fisher & paykel healthcare (fph) in (b)(4) for investigation.It was visually inspected, and the residue found inside the chamber was subsequently analysed with scanning electron microscopy with x-ray microanalysis (sem-eds).Results: visual inspection revealed that the base of the returned chamber was eroded.A hole was also observed where the base was eroded.Residue was found inside the chamber and around the hole in the base.The residue was further investigated by sem-eds analysis, which revealed that it contained sodium chloride.There was also a general presence of chlorine and sulphur, which covered the internal surface of the chamber base.Conclusion: the residue suggests that the damage was caused by the chamber coming into contact with nebulized drugs, which have very likely caused the reported damaged 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 chemical substances that are used in nebulized drugs.Our user instructions that accompany the mr290v humidification chambers state the following: - "use usp sterile water for inhalation or equivalent." - "set appropriate ventilator alarms.".

Event Description

A healthcare facility in (b)(6) reported via a distributor that water leaked after the humidification system was used for two hours.Further inspection revealed that the base plate of an mr290v vented autofeed humidification chamber had a pinhole.No patient consequence was reported.

• 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: sharon kuruvilla ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6946563
• MDR Text Key: 90305925
• Report Number: 9611451-2017-00960
• 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: 09/15/2017

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: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: 161025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• 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