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

Model Number MR850

Device Problems No Audible Alarm (1019); Output Problem (3005)

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

Event Type  malfunction  

Event Description

A distributor in (b)(4) reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported 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 investigation.

Event Description

A distributor in ireland reported that the audible alarm of a mr850 respiratory humidifier was not functioning.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the pcb of the complaint mr850 respiratory humidifier was returned to fisher & paykel healthcare in new zealand for investigation, where it was visually inspected and electrically evaluated.Results: visual inspection revealed no signs of impact damage to the returned pcb.Performance testing confirmed audible alarm was not functioning properly.Electrical resistance testing revealed that the reported fault was due to an open circuit in the speaker coil.Conclusion: we are unable to determine what may have caused the open circuit of the returned mr850 pcb.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
• 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, CA 92618-2216 ; 9494534000
• MDR Report Key: 13992804
• MDR Text Key: 294389462
• Report Number: 9611451-2022-00287
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407184
• UDI-Public: (01)09420012407184(10)2101470451(11)210119
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• 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: 2101470451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• 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