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

Model Number	MR850
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional 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 investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in thailand via a fisher & paykel healthcare (f&p) field representative that the audible alarm of a mr850 respiratory humidifier was not functioning properly.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the pcb of the complaint mr850 respiratory humidifier was returned to fisher & paykel healthcare in new zealand for investigation, where it was electrically evaluated.Results: performance testing revealed that the audible alarm of the mr850 was functioning as intended.Conclusion: we are unable to determine the cause of the reported event.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.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in thailand via a fisher & paykel healthcare (f&p) field representative that the audible alarm of a mr850 respiratory humidifier was not functioning properly.There was no patient involvement.

• Brand Name: RESPIRATORY HUMIDIFIER
• Common Device Name: 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, CA 92618 ; 9494534000
• MDR Report Key: 15891580
• Report Number: 9611451-2022-01106
• Device Sequence Number: 20138340
• Product Code: BTT
• UDI-Device Identifier: 09420012407207
• UDI-Public: (01)09420012407207(10)2101951605(11)211213
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 2101951605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 07/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown