MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER

Model Number MR225

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The subject mr225 manual fill humidification chamber has been requested to be returned to fisher & paykel healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in japan reported that a mr225 manual fill humidification chamber was found leaking during patient use.There was no reported patient consequence.

• Brand Name: MANUAL FILL INFANT/PAEDIATRIC HUMIDIFICATION CHAMBER
• Type of Device: HUMIDIFICATION 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: 19150074
• MDR Text Key: 340976095
• Report Number: 9611451-2024-00299
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K913368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

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: MR225
• Device Catalogue Number: MR225
• Device Lot Number: 220519
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2022
• 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 HEALTHCARE MR850 RESPIRATORY HUMIDIFIER; REUSABLE CIRCUIT (UNKNOWN BRAND)