MAUDE Adverse Event Report: RESPIRATORY HUMIDIFIER; BTT

Model Number MR850

Device Problems No Audible Alarm (1019); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr850 respiratory heated humidifier is currently en route to fisher & paykel healthcare(f&p) (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported that the audible alarm of a mr850 respiratory heated humidifier was faulty.There was no reported patient involvement.

Event Description

A distributor in texas reported that the audible alarm of a mr850 respiratory heated humidifier was faulty.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier was received at our fisher & paykel healthcare (f&p) service centre in california where the device was inspected by a trained f&p personnel.The device was performance tested and the audible alarm was checked.Results: performance testings revealed that the audible alarm of the mr850 respiratory humidifier was faulty.Conclusion: we are unable to determine what may have caused the reported failure.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 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.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• MDR Report Key: 11317178
• MDR Text Key: 233260611
• Report Number: 9611451-2021-00146
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407290
• UDI-Public: (01)09420012407290(10)2101404923(11)201125
• Combination Product (y/n): N
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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: 2101404923
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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