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

Model Number	MR850AEU
Medical Device Problem Code	No Audible Alarm (1019)
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 is currently en route to fisher & paykel healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor in india reported that an mr850 respiratory humidifier was faulty.Upon device servicing at the regional office in india, it was discovered that the audible alarm was not functioning.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the subject mr850 respiratory humidifier was received at our fisher & paykel (f&p) regional office in india 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.Our 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 distributor in india reported that an mr850 respiratory humidifier was faulty.Upon device servicing at the regional office in india, it was discovered that the audible alarm was not functioning.There was no patient involvement.

• 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: 20348374
• Report Number: 9611451-2024-00703
• Device Sequence Number: 20846794
• Product Code: BTT
• UDI-Device Identifier: 09420012407207
• UDI-Public: (01)09420012407207(10)2102214721(11)220609
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 2102214721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown