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

Model Number	MR850AEU
Medical Device Problem Codes	No Audible Alarm (1019); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject mr850 respiratory humidifier has been requested to be returned to f&p 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 (b)(6) reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.
Event or Problem Description
A healthcare facility in france reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Corrected data: section g1 - manufacturer contact office: contact person changed to (b)(6).H11: method: the subject mr850 respiratory humidifier was returned to the fisher & paykel (f&p) healthcare service centre in france where it was inspected by a trained f&p healthcare 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 subject mr850 respiratory humidifier confirmed that the audible alarm was not functioning.The unit was repaired and returned to the customer after passing functional and electrical safety tests.Conclusion: we were unable to determine the cause of the reported event.The 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.
Additional Manufacturer Narrative
(b)(4).Corrected data: section h11 - it was later confirmed that in addition to the faulty speaker the device also had exposed wires on the power cord.Section h6 - updated.H11: method: the subject mr850 respiratory humidifier was returned to the fisher & paykel (f&p) healthcare service centre in france where it was inspected by a trained f&p healthcare 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 subject mr850 respiratory humidifier confirmed that the audible alarm was not functioning.Furthermore, visual inspection confirmed that the power cord was damaged with exposed copper wires.The unit was repaired and returned to the customer after passing functional and electrical safety tests.Conclusion: we were unable to determine the cause of the reported fault.During production the electrical connections of the earth wires on all mr850 units are 100% tested for electrical continuity.Any product that fails is rejected.All mr850 units are visually inspected for damaged power cords before release for distribution.This suggests that the damage occurred after it had been distributed.The 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.The mr850 respiratory humidifier complies with the following electrical standards: as/nzs 3200.1.0, can/csa 22.2 no.601.01, ul 60601-1, iec 60601-1.
Event or Problem Description
A healthcare facility in france reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.

• Brand Name: RESPIRATORY HUMIDIFIER
• 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: 19048111
• Report Number: 9611451-2024-00272
• Device Sequence Number: 8472340
• Product Code: BTT
• UDI-Device Identifier: 09420012407207
• UDI-Public: (01)09420012407207(10)2101315018(11)200929
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2024

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: MR850AEU
• Device Catalogue Number: MR850AEU
• Device Lot Number: 2101315018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 05/23/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/16/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown