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

Model Number	MR850ALU
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in chile reported that the audible alarm of an mr850 respiratory humidifier was not functioning properly.There was no reported patient harm.
Additional Manufacturer Narrative
(b)(4) method: the subject mr850 respiratory humidifier was returned to fisher & paykel healthcare in new zealand for investigation, where it was visually inspected and performance tested.Results: visual inspection of the returned device confirmed a piece of lead offcut was found on the speaker cone.Upon removal of the metal piece, the speaker functioned as intended without distortion.Conclusion: the cause of the audible alarm not sounding as intended was due to presence of lead offcut's on the speaker.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: 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: 20564165
• Report Number: 9611451-2024-00733
• Device Sequence Number: 7569448
• Product Code: BTT
• UDI-Device Identifier: 09420012407245
• UDI-Public: (01)09420012407245(10)2103011159(11)240227
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: MR850ALU
• Device Catalogue Number: MR850ALU
• Device Lot Number: 2103011159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown