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

Model Number MR290V

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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 further investigation.We will provide a follow up report upon the completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a distributor that the dome of a mr290v vented autofeed humidification chamber cracked during high flow therapy.No patient consequence was reported.

Manufacturer Narrative

Ps296807 method: the complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: based on the information provided by the customer the complaint chamber was used for high flow therapy.The customer has confirmed that water leaking was visible at the bottom of chamber dome.Conclusion: without the complaint device we are unable to determine what may have caused the reported event.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.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290v chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber also 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.".

Event Description

A healthcare facility in japan reported via a distributor that the dome of a mr290v vented autofeed humidification chamber cracked during high flow therapy.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, 2013 ; NZ 2013
• MDR Report Key: 8201843
• MDR Text Key: 131942109
• Report Number: 9611451-2018-01131
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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: 180622
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1