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

Model Number MR850AEU

Device Problem No Audible Alarm (1019)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A healthcare facility in (b)(6) reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.

Event Description

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

Manufacturer Narrative

(b)(4).(b)(6).H11: method: the subject mr850 respiratory humidifier was returned to the fisher & paykel (f&p) healthcare service centre in france where it was inspected by a trained f&p healthcare service technician.The unit was serviced, and performance tested.Our investigation is based on the information provided by the f&p service technician.Results: performance testing of the subject mr850 respiratory humidifier confirmed that the audible alarm was not functioning.The unit was repaired and returned to the customer after passing functional and electrical safety tests.Conclusion: we were unable to determine the cause of the reported event.The mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the mr850 heater base.In addition, the product technical manual also states that "all servicing procedures should be followed by a humidifier test, and an electrical safety test to ensure proper operation".The mr850 is equipped with visual alarm indicators in addition to the audible alarm.

• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 19048111
• MDR Text Key: 340128109
• Report Number: 9611451-2024-00272
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407207
• UDI-Public: (01)09420012407207(10)2101315018(11)200929
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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: MR850AEU
• Device Catalogue Number: MR850AEU
• Device Lot Number: 2101315018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1