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

Model Number	MR850JHU
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Corrections: section b4: date of this report updated.Section d9: returned to manufacturer ticked, received date updated.Secrion g3: date receieved by manufacturer updated.Section g6: follow up report # updated.Section h2: correction ticked.Section h6: investigation findings (c) and investigation conclusions (d) coding updated.Method: the pcb of the subject mr850 respiratory humidifier was returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.Our investigation is thus based on the evaluation of the subject device, the information provided by the healthcare facility and our knowledge of the product.Results: testing of the subject pcb confirmed that no sound was generated from the speaker.Additional resistance testing identified an open circuit in the speaker's coil.Conclusion: the cause of the speaker failure was an open circuit condition of the speaker coil.The mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the mr850 respiratory humidifier.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 healthcare facility in (b)(6) reported that the audible alarm of the mr850 respiratory humidifier was not functioning.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr850 respiratory humidifier was returned at our fisher & paykel (f&p) healthcare regional officec in the usa where it was inspected by a trained f&p healthcare service technician.Our investigation is thus based on the information provided by the f&p healthcare service technician, the information provided by the healthcare facility and our knowledge of the product.Results: testing of the subject device observed that no sound was generated from the speaker, confirming the reported issue.Conclusion: without the return of the subject device, we are unable to determine the exact cause of the reported issue.The mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the mr850 respiratory humidifier.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 healthcare facility in (b)(6) reported that the audible alarm of the mr850 respiratory humidifier was not functioning.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Additional Manufacturer Narrative
(b)(4).We have requested the return of the subject mr850 respiratory humidifier for investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in california reported that the audible alarm of the mr850 respiratory humidifier was not functioning.There was no patient involvement as the issue was found whilst the device was not in use on a patient.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: 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: 22846838
• Report Number: 9611451-2025-00792
• Device Sequence Number: 8458017
• Product Code: BTT
• UDI-Device Identifier: 09420012407290
• UDI-Public: (01)09420012407290(10)2101585475(11)210406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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: MR850JHU
• Device Catalogue Number: MR850JHU
• Device Lot Number: 2101585475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 06/01/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/29/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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