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

Model Number MR290V

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found leaking water before patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chamber is currently en route to fisher & paykel healthcare (f&p) in new zealand for evaluation.We will provide a follow-up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Corrected data: section b4.Date of this report (dd-mmm-yyyy): 18-sep-2023.Section g3.Date received by manufacturer (dd-mmm-yyyy): 18-sep-2023.The complaint mr290v vented autofeed humidification chamber is currently en route to fisher & paykel healthcare (f&p) in new zealand for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher & paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found leaking water before patient use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information provided by the customer, and our knowledge of the product.Result: the healthcare facility reported that a chamber was found leaking water before patient use.It was further reported that the complaint chamber was a non-f&p device.Conclusion: without the return of the complaint device, we are unable to determine the cause of the reported event.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber 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.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." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.".

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found leaking water before patient use.There was no patient involvement.

• Brand Name: VENTED AUTOFEED 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17822420
• MDR Text Key: 324330870
• Report Number: 9611451-2023-00912
• 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: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 RT330 OPTIFLOW JUNIOR TUBING KIT; F&P RT330 OPTIFLOW JUNIOR TUBING KIT; F&P RT330 OPTIFLOW JUNIOR TUBING KIT