MAUDE Adverse Event Report: RESPIRATORY HUMIDIFIER; BTT

Model Number	MR850
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are in the process of finalising our investigation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported on behalf of a healthcare facility in (b)(6)that the audible alarm of an mr850 respiratory heated humidifier was not working.There was no patient involvement.
Event or Problem Description
A healthcare facility in sweden reported on behalf of a healthcare facility in south africa that the audible alarm of an mr850 respiratory humidifier was not working.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint mr850 respiratory humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: the customer reported that the audible alarm of an mr850 respiratory humidifier was not working.Conclusion: without the complaint device, 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 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
• MDR Report Key: 11173144
• Report Number: 9611451-2021-00047
• Device Sequence Number: 17036928
• Product Code: BTT
• UDI-Device Identifier: 09420012407184
• UDI-Public: (01)09420012407184(10)2101208131(11)200720
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 2101208131
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/17/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• 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