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

Model Number MR850

Device Problems No Audible Alarm (1019); No Audible Prompt/Feedback (2282)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representative the audible alarm of a mr850 respiratory humidifier was not functioning.There was no patient involvement.

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 our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier was returned to the fisher & paykel healthcare (f&p) service center in california 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 mr850 respiratory humidifier confirmed that the audible alarm was not functioning.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.

Event Description

A healthcare facility in france reported via a fisher & paykel healthcare (f&p) field representativethat the audible alarm of a mr850 respiratory humidifier was not functioning.There was no patient involvement.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: 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 92618 ; 9494534000
• MDR Report Key: 14681910
• MDR Text Key: 295692338
• Report Number: 9611451-2022-00553
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407221
• UDI-Public: (01)09420012407221(10)2101413757(11)201130
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 2101413757
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1