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

Model Number MR850

Device Problem Fire (1245)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

A customer reported an incident in which smoke/flame was observed coming from an mr850 respiratory humidifier during use.It was reported that the patient breathed in smoke however no further patient consequences were reported.Visual inspection of the complaint device did not identify any evidence of smoke or fire damage to the external case.The device has been returned to fph for further analysis.

Manufacturer Narrative

(b)(4).We are currently in the process of assessing the returned device.We will provide a follow-up report upon completion of our investigation.A separate event involving the humidification chamber was also reported by this customer and this has been raised as mfr report # 9611451-2023-00765.

Manufacturer Narrative

(b)(4).A separate event involving the humidification chamber was also reported by this customer and this has been raised as mfr report # 9611451-2023-00765.Method: the complaint mr850 respiratory humidifier was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned mr850 respiratory humidifier indicated no obvious external damage aside from a small crack at the bottom of the front enclosure.An internal inspection identified the presence of black soot within the case and on the transformer.No other abnormalities were noted within the case.Our analysis indicated that the transformer was the most likely source of the smoke/flame that was reported as coming from the mr850 respiratory humidifier during use.On inspection, the damage was clearly localised to the transformer and further inspection of the transformer identified that there was an overheated section (melted plastic) near the primary windings of the transformer.The transformer was sent to the supplier for further analysis.The investigation conducted by the transformer manufacturer found evidence that the primary thermal fuse had failed in a manner that created an intense heat source, permanently damaging the fuse.The transformer supplier confirmed that the correct thermal fuse had been used during manufacture and that there has been no change to the production process of this transformer.Conclusion: our investigation confirmed that the source of the smoke/flame was the transformer.The transformer manufacturer confirmed that the root cause was a failure of the thermal fuse however as this component was destroyed by the event, no further analysis was possible.Analysis of post market data confirmed that this is an isolated event with no previous reports of the transformer failing in this manner.The transformer is designed to remain electrically and thermally safe in a fault condition.The mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking, performance and electrical safety 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 respiratory humidifier is compliant with the following electrical standards: as/nzs 3200.1.0, can/csa 22.2 no.601.01, ul 60601-1, iec 60601-1.This includes the use of fire retardant case materials.

Event Description

A customer reported an incident in which smoke/flame was observed coming from an mr850 respiratory humidifier during use.It was reported that the patient breathed in smoke however no further patient consequences were reported.Visual inspection of the complaint device did not identify any evidence of smoke or fire damage to the external case.The device has been returned to fph for further analysis.

• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17569521
• MDR Text Key: 321400465
• Report Number: 9611451-2023-00690
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012407290
• UDI-Public: (01)09420012407290(10)2101466670(11)210116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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
• Device Operator: Other
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 2101466670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2021
• 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
• Treatment: F&P HC300 HUMIFICATION CHAMBER; F&P HC300 HUMIFICATION CHAMBER; RESMED ASTRAL 150 VENTILATOR; RESMED ASTRAL 150 VENTILATOR; RESPIRONICS 1073221 VENTILATOR CIRCUIT; RESPIRONICS 1073221 VENTILATOR CIRCUIT
• Patient Age: 2.5 YR