MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE FISHER AND PAYKEL HEALTHCARE; RESPIRATORY HUMIDIFIER, PRODUCT CODE: BTT

Model Number	MR850JSU
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) 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.
Event or Problem Description
A healthcare facility in ecuador reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no patient involvement reported.
Additional Manufacturer Narrative
(b)(4).Section g4: the mr850jsu respiratory humidifier is not sold in the usa but is similar to a product which is sold in the usa.The 510(k) for that product is k110019.Section h11: method: the subject mr850 respiratory humidifier was received at our fisher & paykel (f&p) regional office in california where it was inspected by a trained f&p service technician.Our investigation is based on the information provided by the f&p service technician, information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: performance testing of the subject mr850 respiratory humidifier confirmed that no sound was generated from the speaker.Conclusion: the root cause of the speaker fault was not determined.The mr850 respiratory humidifier 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 respiratory humidifier is equipped with visual alarm indicators in addition to the audible alarm.
Event or Problem Description
A healthcare facility in ecuador reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no patient involvement reported.
Event or Problem Description
A healthcare facility in ecuador reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no patient involvement reported.
Additional Manufacturer Narrative
(b)(4).Section g4: the mr850jsu respiratory humidifier is not sold in the usa, but is similar to a product which is sold in the usa.The 510(k) for that product is k110019.Section h11: method: the subject pcb of the mr850 respiratory humidifier was returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.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 in the speaker coil.The mr850 respiratory humidifier 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 respiratory humidifier is equipped with visual alarm indicators in addition to the audible alarm.

• Brand Name: FISHER AND PAYKEL HEALTHCARE
• Common Device Name: RESPIRATORY HUMIDIFIER, PRODUCT CODE: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE; 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 21770118
• Report Number: 9611451-2025-00286
• Device Sequence Number: 21287522
• Product Code: BTT
• UDI-Device Identifier: 09420012407306
• UDI-Public: (01)09420012407306(10)2102559151(11)230323
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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: MR850JSU
• Device Catalogue Number: MR850JSU
• Device Lot Number: 2102559151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/26/2025; 07/18/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/26/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown