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

Model Number MR290V

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device is currently en route to fisher & paykel healthcare in (b)(4) for evaluation, to determine if it had a malfunction which might have lead to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(4) reported via a fisher & paykel healthcare field representative that there was water puddling underneath three mr290 vented humidification chambers.No patient consequence was reported.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that there was water puddling underneath an mr290 vented humidification chamber.No patient consequence was reported.

Manufacturer Narrative

(b)(4) method: the complaint mr290v vented autofeed humidification chamber was returned to fph in (b)(4), and was visually inspected.The lot number of the complaint chamber was revealed to be 2100022321.Results: visual inspection revealed horizontal crack on the chamber dome.The crack was located between the baffle, and one of the ports.Conclusion: we were unable to determine what had caused the cracking on 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, the healthcare facility reported that the damage occurred during use, which suggests that the subject mr290 chamber became damaged after it was released for distribution.Our user instructions that accompany the mr290 state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "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.".

• 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: 7136539
• MDR Text Key: 95770172
• Report Number: 9611451-2017-01231
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 2100022321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1