MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER

Model Number MR850

Device Problem No Audible Alarm (1019)

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

Event Type  malfunction  

Event Description

A distributor in japan reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).The subject mr850 respiratory humidifier has been requested to be returned to fisher & paykel healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: RESPIRATORY HUMIDIFIER
• 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: 19161201
• MDR Text Key: 341589443
• Report Number: 9611451-2024-00288
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407276102
• UDI-Public: (01)09420012407276102(10)2260390(11)22071321220713611031
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

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 Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 220713611031
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1