MAUDE Adverse Event Report: RESPIRATORY HUMIDIFIER; BTT

Model Number	MR850
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
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) in (b)(4).We will provide a follow up report upon completion of investigaion.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the audible alarm of an mr850 respiratory heated humidifier was distorted.There was no patient involvement.
Additional Manufacturer Narrative
Ps(b)(4).Method: the complaint mr850 respiratory humidifier was returned to the fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and functionally tested.Results: device testing revealed that the audible alarm of the mr850 respiratory humidifiers was found distorted.Visual inspection revealed that the diaphragm of the speaker had two pieces of metal offcuts stuck to it.Conclusion: the cause of the speaker faulty is likely due to the remnants of metal offcuts stuck to the speaker diaphragm.Our mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checks and performance tests 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.The user instructions accompanying the mr850 respiratory humidifier states the following in the set-up instructions: - after turning on the humidifier, look at the display and alarm indicators to visually confirm that they turn on and off.Following this, listen for an audible tone to confirm that the sounder is functioning correctly.If a fault is detected, send for servicing.
Event or Problem Description
A healthcare facility in slovenia reported via a fisher & paykel healthcare (f&p) field representative that the audible alarm of an mr850 respiratory heated humidifier was distorted.There was no patient involvement.

• Brand Name: RESPIRATORY HUMIDIFIER
• Common Device Name: BTT
• MDR Report Key: 11226299
• Report Number: 9611451-2021-00087
• Device Sequence Number: 19465278
• Product Code: BTT
• UDI-Device Identifier: 09420012411631
• UDI-Public: (01)09420012411631(10)2101175967(11)200627
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 2101175967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 04/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2020
• 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