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

Model Number MR290V

Device Problem Degraded (1153)

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

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented auto feed humidification chambers was returned to fisher & paykel healthcare in (b)(4) for investigation.The complaint chamber was visually inspected for the reported damage.Results: visual inspection revealed that there was a white and brown residue found inside and outside the chamber.It was further revealed that ther were two holes in the base of the subject chamber.Conclusion: it is likely that the use of the nebulizing drug bromhexine hydrochloride caused the damage to the subject chamber.Moreover the excessive use of the subject chamber may have contributed to the damage.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.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.The subject mr290v chamber would have met the required specification at the time of production.Moreover, the hospital reported that the damage occurred after a period of use, which suggests that the subject mr290 chamber became damaged after it was released for distribution.Our user instructions that accompany the mr290v vented auto feed humidification chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers"."set appropriate ventilator alarms"."perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient"."use usp sterile water for inhalation or equivalent".Our user instructions that accompany the rt265 infant dual-heated evaqua2 breathing circuit kit state the following: "this product is intended to be used for a maximum of 7 days".

Event Description

A hospital in (b)(6) reported, via a distributor, that the water in the mr290v humidification chamber was found "muddy" after 2 weeks of use.The chamber was removed from patient use.Two days later when examined, pinholes were found in the base of the subject chamber.It was confirmed that the nebulizing drug bromhexine hydrochloride was used during therapy.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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7723874
• MDR Text Key: 115545429
• Report Number: 9611451-2018-00628
• 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: 06/28/2018

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: 171129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• 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