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)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in france reported 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).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 healthcare facility in france reported 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 complaint (b)(4) respiratory humidifier was returned to the fisher & paykel healthcare (f&p) service center in france where it was inspected by a trained f&p service technician.The unit was serviced, and performance tested.Our investigation is based on the information provided by the f&p service technician.Results: performance testing of the complaint (b)(4) respiratory humidifier confirmed that the audible alarm was not functioning properly.The unit was repaired and returned to the customer after passing functional and electrical safety tests.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 states that "all servicing procedures shall be followed by a humidifier functional 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: 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: 15891676
• Report Number: 9611451-2022-01105
• Device Sequence Number: 14767109
• Product Code: BTT
• UDI-Device Identifier: 09420012407221
• UDI-Public: (01)09420012407221(10)2101346358(11)201019
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 2101346358
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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
• Patient Sex: Unknown