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

Model Number MR850

Device Problems No Audible Alarm (1019); Output Problem (3005)

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

Event Date 04/08/2022

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

(b)(4).The complaint mr850 respiratory humidifier is 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 illinois reported that the audible alarm of a mr850 respiratory humidifier was not functioning properly.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier was returned to the fisher & paykel healthcare (f&p) service center in california where it was inspected by a trained f&p personnel.The device was performance tested and the audible alarm was checked.Results: performance testing revealed that the audible alarm of the mr850 respiratory humidifiers was working.Conclusion: we are unable to determine what may have caused the reported failure as there was no fault found with the returned device.Our 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: BTT
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine 92618 ; 9494534000
• MDR Report Key: 14231916
• MDR Text Key: 294658693
• Report Number: 9611451-2022-00404
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407290
• UDI-Public: (01)09420012407290(10)2101501719(11)210210
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 2101501719
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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