MAUDE Adverse Event Report: VENTED AUTOFEED HUMIDIFICATION CHAMBER; BTT

Model Number MR290

Device Problems Break (1069); Crack (1135); Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

Ps339155.The complaint mr290 vented autofeed humidification chambers are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that six mr290 vented autofeed humidification chambers were broken and leaking water.During device assessment at our regional office in (b)(6), two mr290v chambers displayed cracks near the bottom of the chamber.There was no patient consequence.

Event Description

A healthcare facility in switzerland reported via a fisher & paykel healthcare (f&p) field representative that six mr290 vented autofeed humidification chambers were broken and leaking water.There was no patient consequence.

Manufacturer Narrative

Ps339155 d4 correction: the lot number was corrected from 2100917188 to 190604 and 190605.Device 1: lot 190604 dom 06/04/2019 device 2: lot 190605 dom 06/05/2019 device 3-6: lot unknown, not provided.Method: three complaint mr290v vented autofeed humidification chambers were returned to fisher & paykel healthcare (f&p) in new zealand and were visually inspected.Results: visual inspection of devices 1 and 2 revealed that the returned devices had a cracked dome.It was also found that the ink of chambers 1 and 2 were smeared.There was no fault found with device 3.Conclusion: the cracked dome found with devices 1 and 2 were most likely caused by contact with an unknown solvent, as indicated by the smeared ink.Based on previous investigations of similar complaints, solvents that contains alcohol can attack dome material and subsequently cause the dome to crack.There was no fault found with device 3.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 chambers would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed 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.".

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: BTT
• MDR Report Key: 10067925
• MDR Text Key: 202086796
• Report Number: 9611451-2020-00482
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290
• Device Catalogue Number: MR290
• Device Lot Number: 190604,190605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: F&P BC160-10 BUBBLE CPAP DELIVERY SYSTEM; F&P BC160-10 BUBBLE CPAP DELIVERY SYSTEM; F&P MR850 RESPIRATORY HUMIDIFER; F&P MR850 RESPIRATORY HUMIDIFER